The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

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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. 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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 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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 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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 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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

The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Official Title

The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial

Brief Summary

      The study objective is to verify if a non-invasive remote ischemic preconditioning procedure
      (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve
      replacement surgery.

Study Type

Interventional

Primary Outcome

Change in biochemical markers of myocardial ischemia

Secondary Outcome

 Post-operative complications

Condition

Aortic Valve Stenosis

Intervention

Blood pressure cuff inflation

Study Arms / Comparison Groups

 Control group
Description:  Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.
A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia.

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

Procedure

Estimated Enrollment

140

Start Date

April 11, 2014

Completion Date

December 1, 2020

Primary Completion Date

July 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Planned isolated aortic valve replacement (stenosis based)

          -  Age ≥ 18 years

        Exclusion Criteria:

          -  Pregnancy

          -  Left ventricular dysfunction (LVEF< 50%)

          -  Myocardial Infarct (< 7days)

          -  Coronary artery disease (documented with >50% stenosis)

          -  Coronary artery bypass grafting

          -  Chronic renal insufficiency (creatinine >175 mmol/L or dialysis)

          -  Endocarditis

          -  Sternotomy redo

          -  Deep vein thrombosis to the compressed limb

          -  Emergency procedure

          -  TAVI procedure

          -  Planned off pump coronary artery bypass

          -  MAZE procedure

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pierre Voisine, MD, ,

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT03305094

Organization ID

CONDOR-21082

Responsible Party

Principal Investigator

Study Sponsor

Laval University

Collaborators

 Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study Sponsor

Pierre Voisine, MD, Principal Investigator, University Laval

Verification Date

April 2020