PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

October 27, 2020 updated by: Edwards Lifesciences

Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.

Follow-up Intervals: 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 month annually for 5 years.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1019
        • Medizinische Universitat Wien Univ.Klinik f.Chirurgie
  • France
      • Paris, France, 75018
        • Hospital Bichat
  • Germany
      • Bad Bevensen, Germany, 29549
        • Herz-Und Gefasszentrum Bad Bevensen
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik
      • Bad Neustadt An Der Saale, Germany, 97616
        • Herz-und-Gefass Klinik
      • Bad Oeynhausen, Germany, 32545
        • Herz-und Diabeteszentrum NRW
      • Bad Rothenfelde, Germany, 49214
        • Schüchtermann-Klinik
      • Cologne, Germany, 50924
        • Heart Center University Cologne
      • Dresden, Germany, 01307
        • Herzzentrum Dresden GmbH
      • Erlangen, Germany, 91054
        • University Clinic Erlangen
      • Essen, Germany, 45122
        • University Hospital Essen, West German Heart Center
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf
      • Karlsruhe, Germany, 76185
        • Cardiac Surgery Karlsruhe
      • Leipzig, Germany, 04829
        • Heart Center Leipzig
      • Munich, Germany, 80636
        • German Heart Center Munich
      • Munich, Germany, 81377
        • University Hospital Munich-Grosshadern
      • Munich, Germany, 81925
        • Hospital Munich-Bogenhausen
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, SE1 7EH
        • St. Thomas' Hospital - NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  1. EuroSCORE of ≥ 15 %
  2. Severe senile degenerative aortic valve stenosis
  3. Symptomatic aortic valve stenosis
  4. Informed consent
  5. Compliance

Exclusion:

  1. Logistic Euroscore > 40 %
  2. Evidence of an acute myocardial infarction
  3. Congenital unicuspid or congenital bicuspid valve/ non-calcified
  4. Mixed aortic valve disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAVR-TA
Transcatheter valve replacement with transapical access
Device: SAPIEN XT™ Transapical aortic valve replacement
Transcatheter aortic valve implantation via the transapical approach
Other Names:
  • Sapien XT
  • Next generation Ascendra delivery system inclusive accessory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Deaths
Time Frame: 30 days
Number of death at 30-days from the index procedure.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Stroke
Time Frame: 30-days
Total Number of Participants with a Stroke.
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Prof. Dr. Thomas Walther, Kerckhoff Klinik
  • Principal Investigator: Dr. Olaf Wendler, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Valve Stenosis

Clinical Trials on SAPIEN XT™ Transapical aortic valve replacement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe