VALVOSOFT® Pivotal Study

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Aortic valve stenosis
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Outcome, Recuperation and Hemodynamics in Aortic Stenosis Effect of Colchicine on the Progression of Aortic Valve Stenosis – A Pilot Study Oxford – Fibrates in Aortic Stenosis Acute STROke Complicating TAVI – Management and Outcomes Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients Effect of Dapagliflozin on Myocardial and Renal Function Following Aortic Valve Stenosis Intervention Neuropsychological and Neuroimaging Evaluation of the Cognitive Impairment in Aortic Valve Replacement (ARTiCO) EffecTAVI Registry VALVOSOFT® Pivotal Study Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial Transcatheter Aortic Valve Replacement (TAVR) Double Balloon Valvuloplasty DurAVR™ THV System: First-In-Human Study MRI in Randomised Cohorts of Asymptomatic AS Portico India Clinical Trial China S3 PMS: SAPIEN 3 China Post Market Registry Study Colchicine and Inflammation in Aortic Stenosis INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi) Evolut™ EXPAND TAVR II Pivotal Trial Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation Anxiety Reduction in TAVI Using Virtual Reality Trial Brain Microbleeds After Transcatheter Aortic Valve Replacement OpSens PRIME CLASS The Leaflex™ Brazilian Standalone Study RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and loCal anestHesia vs. cOnscIous Sedation in transCathEter Aortic Valve Implantation Left Bundle Branch Area Pacing in Patients After TAVR LUS in Aortic Stenosis Patients Undergoing TAVR The Leipzig TAVI Registry Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis On Dose Efficiency of Modern CT-scanners in Chest Scans Portico Valve-in-Valve Retrospective Registry NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China Effect of PCSK9 InhibitorS On Calcific Aortic Valve DiseasE Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement Coronary Artery Disease in Elderly People Referred for TAVI TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation. Angiotensin Receptor Blockers in Aortic Stenosis PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis SAPIEN 3 Ultra EU PMS PrizValve® Transcatheter Aortic Valve Replacement Study Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR Early neo2 Registry of the Acurate neo2 TAVI Prosthesis IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency HANGZHOU Solution in Bicuspid AS Undergoing TAVR Myeloid Cells in Aortic Valve Stenosis Clinical Study of a Novel Transcatheter Anti-embolic Filter for Cerebral Protection During Aortic Valve Interventions Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis – RO-TAVI Cerebral Lesion and Neurocognitive Status Changes After TAVR VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis The Leaflex™ Standalone Study Protocol Evaluating Infrasonic Hemodynography Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement The Leaflex™ Early Feasibility Study Mechanisms of Excess Risk in Aortic Stenosis Sentinel Low Risk Registry Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis transShield Embolic Protection System Feasibility Study The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients. SAPIEN 3 Ultra System PMCF Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation The HALT Biomarker Study Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis Epitranscriptomic Blood Biomarkers for Coronary Artery Disease – A Prospective Cohort Study (IHD-EPITRAN) Atherosclerotic Plaque Burden Distribution Among Patients With VHD Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients Non-contrast 3-dimensional Cardiac Magnetic Resonance Imaging Multicenter Study Evaluating the Efficacy of an Intervention Aimed at Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation 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

VALVOSOFT® Pivotal Study

Official Title

Prospective, Single-arm Pivotal Study for the Treatment of Subjects With Severe Symptomatic Calcific Aortic Valve Stenosis Using Valvosoft® Non-Invasive Ultrasound Therapy (NIUT)

Brief Summary

      The objective of the study is to evaluate the safety and performance of a new non-invasive
      ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

Study Type

Interventional

Primary Outcome

Safety endpoint

Secondary Outcome

 Rate of MACE

Condition

Aortic Valve Calcification

Intervention

VALVOSFT intervention

Study Arms / Comparison Groups

 Valvosoft
Description:  Treatment with VALVOSOFT device

Publications

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

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

60

Start Date

June 15, 2022

Completion Date

January 15, 2023

Primary Completion Date

January 15, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Subject suffering from severe symptomatic calcific aortic valve stenosis as defined by
             ESC/EACTS guidelines for the management of valvular heart disease 2021; and

          2. Subject is not recommended by the local HEART Team for immediate TAVR/SAVR; or

          3. Subject who refuses TAVR/SAVR, documented by local HEART Team; and

          4. Age ≥18 years; and

          5. Subject willing to provide a written informed consent prior to participating in the
             study; and

          6. Subject who can comply with the study follow-up or other study requirements; and

          7. Subject is eligible for the Valvosoft procedure according to Clinical Review Committee
             (CRC).

        Exclusion Criteria:

          1. Subject with severe aortic regurgitation; or

          2. Subject with unstable arrhythmia not controlled by medical treatment; or

          3. Subjects with implanted mechanical valve in any position or bio-prosthetic valve in
             aortic position; or

          4. Subject has a chest deformity not allowing optimal placement of Valvosoft Applicator
             and visualization of the aortic valve; or

          5. Cardiogenic shock or other hemodynamic instability; or

          6. Left Ventricular Ejection Fraction ≤30%; or

          7. Subject with mean AVAI <0,24 cm²/m2; or

          8. History of heart transplant; or

          9. Subject requiring other cardiac surgery procedures (bypass graft surgery, mitral valve
             procedure, tricuspid valve procedure) within one month after Valvosoft procedure; or

         10. Cardiac imaging evidence of vegetation; or

         11. Acute myocardial infarction (MI) within one month prior to enrolment; or

         12. Valve depth not suitable for NIUT (depth >125mm with respect to the Valvosoft imaging
             probe); or

         13. Stroke or transient ischemic attack (TIA) ≤1 month prior to enrollment; or

         14. Subject who is pregnant, or plan to become pregnant during the 12-months study
             follow-up period; or

         15. Subject who is participating in another research study for which the primary endpoint
             has not been reached; or

         16. Balloon aortic valvuloplasty (BAV) ≤3 months prior to enrollment; or

         17. Current endocarditis; or

         18. Leukopenia (WBC <4000 cell/μL), anemia (Hgb <8 g/dL), thrombocytopenia (platelet count
             <15.000 cell/μL), or history of coagulopathy or hypercoagulable state; or

         19. Life expectancy < 6 months due to non-cardiac co-morbid conditions; or

         20. Other medical, psychological, or social condition which, in the opinion of the
             investigator, precludes the subject from study participation; or

         21. Subjects who do not have Social Security and who are under legal restraint; or

         22. Subjects who cannot read or write or are mentally not or partially capable of giving
             informed consent.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christian Spaulding, MD, PhD, +32 475 84 58 36, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT05235568

Organization ID

CW21-02

Responsible Party

Sponsor

Study Sponsor

Cardiawave SA

Collaborators

 Trium Clinical Consulting

Study Sponsor

Christian Spaulding, MD, PhD, Principal Investigator, HEGP, Paris, France

Verification Date

June 2022