PREVAIL-20J – Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial

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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 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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

PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial

Official Title

A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

Brief Summary

      A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the
      20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral
      delivery system, and crimper accessories. The trial includes a premarket pivotal cohort to
      evaluate the system performance as well as a post market clinical follow-up phase involving
      long term follow-up of all patients to evaluate the safety of investigational devices up to 5
      years.

Detailed Description

      Purpose: To evaluate the safety and efficacy of THV-9300 (20mm) for patients who have severe
      symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet
      and for whom undergoing a surgery safely would be difficult.

      Enrollment: 15 patients (No.of patients needed: 12)

      Follow-up: Subject data collection will include clinical information at baseline and during
      the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 months
      and annually for 5 years.

      Clinical sites:

      1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4)
      Kokura Memorial Hospital

Study Type

Interventional

Primary Outcome

NYHA Improvement and AVA >= 0.65 cm2

Condition

Aortic Valve Stenosis

Intervention

SAPIEN XT NovaFlex delivery system

Study Arms / Comparison Groups

 TAVI-TF Approach
Description:  Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.

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

17

Start Date

June 2011

Completion Date

December 2017

Primary Completion Date

January 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who were judged difficult to safely undergo AVR

          -  Severe senile degenerative aortic valve stenosis

          -  NYHA Functional Class II or greater

          -  Signed Informed Consent

        Exclusion Criteria:

          -  Aortic valve is congenital unicuspid or bicuspid

          -  Annulus size between < 16 mm or > 19 mm

          -  LVEF < 20 %

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Morimasa Takayama, MD, ,

Location Countries

Japan

Location Countries

Japan

Administrative Informations

NCT ID

NCT01419015

Organization ID

EW-P-002

Responsible Party

Sponsor

Study Sponsor

Edwards Lifesciences

Study Sponsor

Morimasa Takayama, MD, Principal Investigator, Sakakibara Heart Institute

Verification Date

July 2020