Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis

Learn more about:
Related Clinical Trial
Conduction Disease After Transcatheter Aortic Valve Replacement Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement SLOW-Slower Progress of caLcificatiOn With Vitamin K2 COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis. Transcatheter Aortic Valve Implantation in Western NORway TMAO in Patients With Severe Aortic Stenosis Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery Spanish Percutaneous Aortic INtervention REGISTRY (SPAIN REGISTRY) Physical and Functional Recovery From Cardiac Surgery in Hospitalized Patients: A Feasibility Pilot Study Genomic Investigation of Cardiovascular Diseases Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery Logical Analysis of Data and Cardiac Surgery Risk Automated Phonocardiography Analysis in Adults ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE) Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation The CardioPAT Project: A Randomized Trial Risk Stratification Post TAVI Using TEG Structural Heart and Valve Network PROSPECTIVE Registry Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra Cardiovascular Health Improvement Project Water- and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000 Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX Neuroprotection in Patients Undergoing Aortic Valve Replacement Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation Quality of Life After Cardiac Surgery Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study Progel Vascular Sealant The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose Long Term Follow Up Study of the St. Jude Medical Trifecta Valve Balloon Valvuloplasty Registry Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease Anticoagulation for Aortic Bioprosthesis (ANTIPRO) Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support. Evaluation of Cerebral Thrombembolism After TAVR Preventive Heart Rehabilitation to Prevent Complications in Patients Undergoing Elective Open Heart Surgery Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes Polymorphisms in the Vitamin D System and Health Exercise Training After Transcatheter Aortic Valve Implantation An Observational, Prospective Evaluation of the Trifecta™ Valve Aortic Valve Replacement With Trifecta(TM) Aortic Valve Replacement With Trifecta(TM) Rivaroxaban or Aspirin for Biological Aortic Prosthesis Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The ‘LYTEN’ Trial PROACT Xa – A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban Transcatheter Aortic Valve Implantation Without Predilation Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI J-Valve Compassionate Use Radial Versus Femoral Secondary Access During TAVI Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement Near INfrared Spectroscopy in Aortic valvE ReplacemenT Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers. The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery Perceval S Aortic Heart Valve Study- North America Cerebral Oxymetry at Elective Coronary and Valve Surgery. Dual Antiplatelet Therapy Versus Oral Anticoagulation for a Short Time to Prevent Cerebral Embolism After TAVI Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT) Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions Better Patient Selection to Transcatheter Aortic Valve Implantation China Valve Registry Study-1 Depression and Major Adverse Events in Older Patients Who Undergo a Transcatheter Aortic Valve Implantation Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in AF Undergoing TAVI Remote ECG Monitoring of TAVI Patients Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement Stent Geometry in Sutureless Bioprosthetic Valves Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves The Asian Transcatheter Aortic Valve Replacement Registry Pilot Trial: Comparison of Flow Patterns Cardiac Function After Minimally Invasive Aortic Valve Implantation The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II – PARTNER II – Nested Registry 3/Valve-in-Valve Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry CardioCel Tri-leaflet Repair Study Freedom SOLO Stentless Heart Valve Study Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS) Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures – Part II Pressure Assessment to Improve Outcomes After TAVR: a Registry Von Willebrand Factor As a Biological Sensor of Blood Flow in Percutaneous Cardiac Procedure Prevalence and Significance of Mutations in Genes Encoding NaPi-co-transporters in the Development of CAVD Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation Comparative Imaging Assessment of Valvular Heart Disease The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention – The TAVI PCI Trial Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes The PARTNER 3 – AVIV Trial Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation. Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in TAVI The Italian Society of Invasive Cardiology Registry on Percutaneous Aortic Valve German TAVI-Register EDWARDS INTUITY Valve System FOUNDATION Study Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) Does Cardiac REhabilitation Improve Functional, Independence, Frailty and Emotional outCOmes Following Trans Catheter Aortic ValvE Replacement? Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement Remote Ischemic Preconditioning for Renal Protection in TAVI Avr Thrombosis OutcoMe Study PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry Virtual Reality Assisted Conscious Sedation During TAVI The Aortic Valve DECalcification (AVADEC) Trial Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial) Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta. Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System Remote Ischemic Preconditioning in Aortic Valve Surgery REST Study: Left Ventricular Regression European Study Concentration of Plant Sterols in Serum and Aortic Valve Cusps Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease Engager Direct Aortic Clinical Study A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device Coronary and Structural Interventions – Transcatheter Aortic Valve Replacement Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR Desflurane-induced Myocardial Protection Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke The Pacing vs No Pacing Study – PNP Study Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve Everyday Practice With Transcatheter Aortic Valve Implantation The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access A Trial to Assess the Safety and Efficacy of Prophylactic TicagrelOr With Acetylsalicylic Acid Versus CLopidogrel With Acetylsalicylic Acid in the Development of Cerebrovascular EMbolic Events During TAVI Can Rehabilitation After TAVI Precipitate Recovery and Improve Prognosis Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3 Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects Safety and Feasibility of Early Discharge for Transfemoral Transcatheter Aortic Valve Replacement The Prospective Segeberg TAVI Registry Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement Inflammatory Response to Aortic Valve Replacement Risk Factors Associated With Calcification of the Aortic Valve Vascular Closure Device in Transcatheter Aortic Valve Replacement Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation Hamburg AoRtic Valve cOhoRt Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI) Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK Self-Centering Guide Catheter Feasibility Study Dedicated Sheath Feasibility Study Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery Low-dose-contrast Cardiac Computed Tomography CoreValve Evolut Pro Registry 18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes Conscious Sedation vs General Anesthesia in TAVR Patients Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients Inflammatory Response in Aortic Valve Replacement CoreValve Advance-II Study: Prospective International Post-market Study Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement EDWARDS INTUITY Elite Valve System Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population Physical Activity in Patients After Aortic Valve Replacement (Valve-ex) Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation The preDIlatation in tRanscathEter aortiC Valve implanTation Trial Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe) Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement Platelet Reactivity After TAVI: A Multicenter Pilot Study Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical) Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI Assessments of Thrombus Formation in TAVI Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography TAVI Protocol – Paravertebral Block Study Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System ADVANCE Direct Aortic Study German Aortic Valve Registry Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF) Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study A STEP for Patients Prior to Undergoing TAVR: A Pilot Study Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve Engager Align Post-market Clinical Study Improved HRV, Inflammation Markers and Endothelial Function After TAVI Diagnostic Three Dimensional Echocardiography Study Protocol DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT The Asian Pacific TAVR Multicenter Registry Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Replacement System Pivotal Trial Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves. Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. Pilot Study of Cognitive and Functional Outcomes Following TAVI Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement SOURCE XT REGISTRY Imaging Histone Deacetylase in the Heart A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement The PARTNER II Trial: S3iCAP Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development First in Man Study of the JenaValve TAVI Plus System Transfemoral Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR Ascending Aortic Dilation in BiAV After TAVR Safety and Performance Study of the Optimum Transcatheter Aortic Valve Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support The TransCatheter Valve and Vessels Trial TAVR Without Predilatation Safety and Efficacy Study of MicroPort’s Transcatheter Aortic Valve and Delivery System for TAVI Enable® Aortic Sutureless Bioprosthesis Evaluation Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum) HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan PREVAIL-20J – Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial RESPOND EDGE Post Market Study Impact of SAVR and TAVR on Patient’s Activity and Mobility BIOVALVE – I / II Clincial Investigation Comparison of Blood and Crystalloid Cardioplegia Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure CoreValve Advance International Post Market Study HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON SWISS TAVI Registry CoreValve™ Evolut R™ FORWARD Study Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial Follow-up After TAVR Without Systematic Intensive Care Unit Admission ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34) Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) ACURATE TA™ Valve Implantation Registry: SAVI 2 Colibri Transcatheter Aortic Heart Valve System Study HLT Meridian Valve CE Mark Trial Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Phono- and Electrocardiogram Assisted Detection of Valvular Disease The Medtronic TAVR 2.0 US Clinical Study PREVAIL-J – Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) Regression of Myocardial Fibrosis After Aortic Valve Replacement Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis THE ALIGN-AS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis Valvuloplasty Scoring Balloon Catheter First-in-Man Study Effect of Angiotensin II Receptor Blockers (ARB) on Left Ventricular Reverse Remodelling After Aortic Valve Replacement in Severe Valvular Aortic Stenosis Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome – (German Pilot) Quality of Care in AS IMPULSE Study Biomarkers in Aortic Stenosis – B.A.S.S. CoreValve® System Australia/New Zealand Clinical Study The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2) Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis Prospective Balloon Aortic Valvuloplasty Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis) Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis Early Surgery for Patients With Asymptomatic Aortic Stenosis Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease Statin Therapy in Asymptomatic Aortic Stenosis Validation of the “TASQ” in Patients Undergoing SAVR or TF-TAVI Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis Improving Echo Measurements in the Diagnosis of Aortic Stenosis accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis – REBOOT-PARADOX Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction Microvascular Dysfunction in Aortic Stenosis Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics Mechanism of Decompensation Evaluation – Aortic Stenosis Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) A Comparison of Advanced Imaging Techniques in Aortic Stenosis Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis Microparticles in Severe Aortic Stenosis Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED) Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis Study to Improve Outcomes in Aortic Stenosis Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study) Severe Aortic Stenosis in Patients Referred for Valve Surgery Frailty and Mortality in Older Old With Severe Aortic Stenosis Myocardial Efficiency of the Left Ventricle in Asymptomatic Patients With Aortic Valve Stenosis – a Prognostic Marker and a Target for Intervention? PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial Angiogenesis and Fibrosis in Aortic Stenosis Acquired Von Willebrand Syndrome in Severe Aortic Stenosis Effect of Bisoprolol on Progression of Aortic Stenosis Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis Effects of Rosuvastatin on Aortic Stenosis Progression Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS) Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis Assessment of Myocardial Tissue Damage in Aortic Stenosis Genetics of Aortic Stenosis: From Family Forms to the Common Forms ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis Genetic of Aortic Valve Stenosis – Clinical and Therapeutic Implications The Role of Myocardial Fibrosis in Patients With Aortic Stenosis Morbidity and Mortality Due to Deferral of Aortic Valve Replacement in Patients With Severe Aortic Stenosis Serum Biomarkers for Aortic Valve Stenosis Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling Aortic Stenosis in Elderly : Determinant of Progression Biological Variation of Cardiac Biomarkers in Aortic Valve Stenosis GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve Vivio AS (Aortic Stenosis) Algorithm Optimization Study Risk Prediction in Aortic Stenosis Acute Haemodynamic Effects of Treatment With Angiotensin Converting Enzyme (ACE)-Inhibitors in Patients With Symptomatic Aortic Stenosis Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis Heart Failure and Aortic Stenosis Transcriptome Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery Vivio AS (Aortic Stenosis) Detection Study Cardiac MRI for Severe Aortic Stenosis Metabolic Determinants of the Progression of Aortic Stenosis Impact of a Patient Decision Aid for Treatment of Aortic Stenosis Early Detection of Aortic Stenosis in the Community During Flu Vaccination Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography The Effect of Lipitor on Aortic Stenosis

Brief Title

Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis

Official Title

Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis

Brief Summary

      This study evaluates and compares aortic calcium by computed tomography and histopathology in
      patients with aortic stenosis.
    

Detailed Description

      1. Title

           Analysis and comparative evaluation of aortic calcium by computed tomography and
           histopathology in patients with aortic stenosis.

        2. Background.

           Calcified aortic valve disease (CAVD) was initially considered to be a passive
           degeneration of the extracellular matrix (EM). Recent studies have shown that within the
           development of the damage mechanism there is complexity and it is an active (1) and
           degenerative process where genetic, environmental and epigenetic phases overlap and
           interact leading to hemodynamic changes in blood flow, endothelial dysfunction and
           metabolic disorders that lead to low-density lipoprotein cholesterol deposits in the ME
           where at the same time there is an underlying infiltration of macrophages, oxidative
           stress, and release of pro-inflammatory cytokines. (2) However, although there are
           several theories of damage, and some of them are attributed to a diversity of origin
           such as genetic, congenital, infectious, and degenerative. Finally, the dynamic and
           functional impact of the heart affects equally. It leads to organic deterioration when
           the AD reaches clinical and echocardiographic criteria of severity, and the only
           therapeutic option is the change or replacement of the aortic valve.

           The participation of imaging methods such as computerized tomography about to the
           concerning the aortic valve through the measurement of the aortic calcium score (AVC-CT)
           as a method to determine the severity of aortic stenosis (AS) in those cases where
           echocardiographic measurements are conflicting, allows us to see the interest in
           defining this problem through different angles of investigation (7). In AD, progressive
           calcification is the trigger factor that also predominantly leads to aortic valve
           obstruction. (3) Currently, such calcification can be easily quantified using the same
           acquisition protocol and Agatston Scoring Method as used for a coronary artery calcium
           scan and is particularly attractive because it provides an assessment of the severity of
           AD, which is independent of the geometry and ventricular ejection fraction. Advances in
           the field of CT CVA measurement have been demonstrated in the last decade and are
           closely associated with hemodynamic measurements of moderate to severe AD in Doppler
           echocardiography, however, until recently, significant over-positioning of calcium from
           the aortic valve area among patients with hemodynamically severe AD and those with
           non-severe AD made it challenging to implement in clinical practice.

           This development has generated significant interest in the use of CT-CVA as an
           alternative and complementary assessment of the severity of AD, especially in patients
           with discordant echocardiographic findings. (11) In fact: 1) CVA is strongly but
           non-linearly associated with hemodynamic measures of severity in moderate to severe AD
           (12). Thus, the determination of CVA may help discriminate severe AD from non-severe AD
           in patients with discordant findings measured by echocardiography, and 3) in patients
           with moderate to severe AD, CVA is also likely associated with faster progression of AD
           and with survival. However, it should be mentioned that the analysis of that series did
           not make adjustments to the calcium measured in the patients' coronary artery. Although
           the CVA score has been recommended in the European Society of Cardiology Guidelines to
           confirm the severity of AD in the following conditions 1) patients with low left
           ventricular ejection fraction (LVEF), gradient and low flow, in which dobutamine stress
           echocardiography is inconclusive and 2) patients with low gradient AD and preserved
           LVEF, and this is not yet part of the American Heart Association (AHA) and American
           College of Cardiology (ACC) guidelines (13).

           So it has been suggested that clinical applicability should be established, so what are
           the next steps? While the reproducibility of coronary calcium quantification by
           multidetector CT has been tested for various workstation platforms before, (14,15) the
           same has not been done so far for CVA quantification through variability with standard
           Gold through the histopathological study and determine the variability of the CVA score
           measured by CT by determining its relationship through the flow and gradient status of
           patients with AD and define what implications can be suggested for the patient's
           treatment(13,16)

        3. Problem statement.

           There is a high prevalence of aortic valve calcification in patients who are subjected
           to valve change regardless of the cause (genetic, congenital, or degenerative structural
           malformation). Early identification of calcification in these patients is critical since
           they will receive a valve change that is likely to return to dysfunction if there is no
           history of the type of damage with or without preceding valve calcification. Currently,
           there is controversy about the ideal time to initiate valve therapy, as it has not been
           possible to identify those patients who will develop significant valve calcification.
           However, little is known about the relationship between the new imaging methods that are
           promising for measuring it and its correlation with standard gold, that is, what is
           quantified at the histopathological level.

           3.1. Justification.

           Magnitude: The global prevalence of aortic stenosis is 0.3-0.5% and 2-7% in >65 years
           and of valvular calcification. According to its definition and criteria to classify
           valve stenosis, up to 30% will require aortic valve change due to valve insufficiency.

           Significance: In the last two decades, the incidence of aortic valve insufficiency has
           increased exponentially and has been associated with unfavorable outcomes.

           Vulnerability: Currently, the cornerstone of aortic stenosis management includes
           prevention and early support management. The identification of calcification has not
           been entirely clear either through laboratory parameters or about to with concerning
           risk factors, which are inadequate and late. Early detection and intervention of
           calcification during the disease can improve the prognosis if it is recognized early.

           Feasibility: The study will be carried out in the two departments of Immunology through
           Dr. Soto who will coordinate the research) (Cardiovascular Medicine through Dr. Israel
           Pérez Torres who will evaluate calcification and histological changes in the valve
           tissue) (Pathology through Dr. Aranda who will manage and treat the valve samples) and
           the Image Department coordinated by Dr. Sergio Críales Vera who will quantify the valve
           calcium). All departments are recognized for their extensive participation in research.

           The study of the pathogenesis of persistent inflammatory damage in aortic stenosis in
           relation to the type of prosthesis will lead in the future to evaluate if it is a factor
           involved in the recurrent damage in stenosis, calcification, and deterioration. In the
           last decades in Mexico, the demographic transition increased the number of people over
           65 years old, the population in which the most significant complication of valve
           dysfunction has been seen. However, regardless of age and etiology, this is currently a
           population group with significant expansion and is expected to triple by 2030. This
           inflammatory damage will increase the prevalence of aortic stenosis, and therefore more
           patients will require valve replacement surgery.

           Our Institute is a national reference hospital that attends a significant number of
           patients with aortic stenosis, among others. Of the valves that are implanted, a quarter
           is manufactured at the Institute. Therefore, evaluating processes highly related to
           valve dysfunction such as calcification is a priority and is considered a health problem
           that requires prevention.

           3.2. Research question.

           In patients who have undergone aortic valve surgery, will the quantification of calcium
           using the 4D computerized tomography method have a reasonable correlation with that
           measured by histopathology, and will it also allow it to be proposed as an early
           predictor of dysfunction?

        4. Hypothesis.

           Working hypothesis (H1): The quantifiable assessment of valve calcium by CT is similar
           to that measured by histopathology and predicts early valve dysfunction.

           Null hypothesis (H0): The quantifiable assessment of calcium by CT scan is different
           from that measured by histopathology and does not predict early valve dysfunction.

        5. Methodology.

           5.1. Study design.

           Cohort, observational, comparative, and prospective study.

           5.2.5. Elimination criteria.

           a) Not having an adequate sample or staining of the valve tissue.

           5.3. Sample size.

           For the calculation of the sample size, a determination of the sample size (two tails)
           shall be made, taking into account the means and standard deviation (SD) of the items
           corresponding to each one. All patients who meet the inclusion criteria described above
           shall be considered for evaluation during the period 2017-2020.

           5.4. Data collection technique

           Data collection will be divided into three stages:

           Pre-surgical:

           Once the study population has been identified, a personal interview will be conducted,
           the objective of the study will be explained to the patient, and informed consent will
           be obtained. Various echocardiographic parameters will be collected for each patient
           (pre-surgical echocardiogram). The study of the valve, which is requested before
           surgery, will be analyzed in a tomography scan, and this is the one that will be used to
           measure the calcium.

           Post-surgery

           Employing the sample of the valve tissue obtained from the surgery, the appropriate cuts
           and stains for the measurement of the calcium will be requested.

           Echocardiographic study.

           The echocardiographic study performed will be re-evaluated by two expert
           echocardiographers following current recommendations.16 The Philips iE33 xMATRIX
           (Philips, Andover Massachusetts) ultrasound system with X5-1 transducer. The dimensions
           of the left ventricle will be quantified in the long parasternal axis; the volumes of
           the left atrium and left ventricle will be calculated with the Simpson method. The
           aortic valve area will be estimated with the continuity equation. The mass of the LV was
           estimated with the Devereaux method.17 The mean and maximum transvalvular aortic
           gradients will be acquired in the apical projection of three or five chambers, where a
           suitable continuous Doppler spectrum and the highest transaortic velocity were obtained.
           The pulmonary artery systolic pressure will be estimated by adding the right atrial
           pressure to the tricuspid insufficiency gradient.

           Computed tomography evaluation.

           The study was performed with a multidetector with double energy source of 256 cuts
           definition Flash Medical Systems Forcheim Germany (128 x 2), performing prospective
           additive in the best diastolic phase (65-70 %), with 3 mm thick reconstructions and 3mm
           spacing with Kernel B 35f filter and visual field adjusted only to the heart. The images
           were processed on a workstation (SmartScore by Syngo via, Waukeesha WI Electronics for
           Medicine. The results were expressed in Agatston units. The study was carried out
           without a contrast medium and with a radiation equivalent to 1.0 mSv.

           Tissue evaluation

           Histological technique.

           A 5-micron segment of the aortic valve, obtained by cardiothoracic surgery, was washed
           in 0.9% NaCl for 30 seconds immediately after the tissues were fixed by immersion in
           phosphate buffer with 10% formalin (pH 7.4) for 24 hours. Histological sections of the
           aortic valve were processed according to conventional histological procedures using Von
           Kossa staining. The technique is based on the reaction of silver nitrate in the presence
           of a reducing agent, usually, hydroquinone, resulting in insoluble silver phosphate that
           can be seen under the microscope in black. Histological sections were analyzed using a
           Carl Zeiss light microscope (Carl Zeiss, West Germany, Germany) (model 63,300) equipped
           with a Tucsen digital camera (9 megapixels) with TSview 7.1 software (Tucsen Imaging
           Technology Co., Ltd. Chuo, Japan, at 25x magnification. The photomicrographs were
           analyzed by densitometry using Sigma Scan Pro 5 Systat Software Inc. San Jose,
           California, CA, USA. Density values are expressed as pixel units.

        6. Statistical analysis plan.

      Categorical variables were expressed as proportions, continuous variables as means with
      standard deviation or median with interquartile range according to the distribution.
      Comparisons will be made for categorical variables with Chi-square or Fisher exact test and
      dimensional variables with Student t or Mann-Whitney U. Correlations with Pearson's r for
      quantitative variables or Spearman's rho for qualitative variables. Related samples were
      analyzed with ANOVA for repeated measurements and Friedman's test according to distribution
      with post-hoc analysis to identify differences between groups. The diagnostic test study will
      include the ROC curve to analyze cut-off points. The p-value of statistical significance was
      established to be less than 0.05 at two-tailed. Statistical analysis was performed with SPSS
      version 22 software (SPSS Inc. Chicago, Illinois).
    


Study Type

Observational


Primary Outcome

The quantifiable assessment and comparison of aortic valve calcium.

Secondary Outcome

 The quantifiable assessmen and comparisont of valve calcium with photomicrographs.

Condition

Aortic Calcification Valve



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

80

Start Date

January 1, 2020

Completion Date

January 30, 2021

Primary Completion Date

January 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Patients who are candidates for aortic valve replacement.

          2. Age greater than or equal to 18 years of age.

          3. Both genders.

          4. With any associated comorbidity

          5. Any etiology

          6. Hospitalized and with an echocardiographic study showing the variables to be studied

          7. Informed Consent.

        Exclusion Criteria:

          1. Patients who have previously undergone other aortic valve surgery

          2. Patients who have received contrast medium ≤24 hours.

          3. Patients on hemodialysis.

          4. Patients with infection.

          5. Patients with cancer.

          6. Patients with autoimmune diseases.

          7. Pregnant women.

          8. Patients who refuse to be included.
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

, 5538880897, [email protected]

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT04344353

Organization ID

19-1139


Responsible Party

Principal Investigator

Study Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez


Study Sponsor

, , 


Verification Date

April 2020