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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01238835
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : February 9, 2017
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: SAPIEN XT™ Transapical aortic valve replacement Not Applicable

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  (Clinical Trial)
Actual Enrollment : 218 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
Actual Study Start Date : September 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Freedom from death [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 5 years ]

    Freedom from:

    • stroke
    • myocardial infarction
    • valve/device related reintervention/reoperation
    • access related complications
    • valve embolization
    • conduction defects requiring permanent pacemaker

  2. Efficacy parameters [ Time Frame: 5 years ]
    • NYHA
    • 6 Minute Walk Test
    • Echocardiographic variables like effective orifice area, peak and mean gradient, aortic insufficiency and perivalvular leak

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01238835

Medizinische Universitat Wien Univ.Klinik f.Chirurgie
Wien, Austria, 1019
Hôspital Bichat
Paris, France, 75018
Herz-Und Gefasszentrum Bad Bevensen
Bad Bevensen, Germany, 29549
Bad Nauheim, Germany, 61231
Herz-und-Gefass Klinik
Bad Neustadt, Germany, 97616
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
Bad Rothenfelde, Germany, 49214
Heart Center University Cologne
Cologne, Germany, 50924
Herzzentrum Dresden GmbH
Dresden, Germany, 01307
University Clinic Erlangen
Erlangen, Germany, 91054
University Hospital Essen, West German Heart Center
Essen, Germany, 45122
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Cardiac Surgery Karlsruhe
Karlsruhe, Germany, 76185
Heart Center Leipzig
Leipzig, Germany, 04829
German Heart Center Munich
Munich, Germany, 80636
University Hospital Munich-Grosshadern
Munich, Germany, 81377
Hospital Munich-Bogenhausen
Munich, Germany, 81925
Stuttgart, Germany, 70376
United Kingdom
St. Thomas' Hospital - NHS Trust
London, United Kingdom, SE1 7EH
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Edwards Lifesciences
Principal Investigator: Prof. Dr. Thomas Walther Kerckhoff Klinik
Principal Investigator: Dr. Olaf Wendler King's College London

Responsible Party: Edwards Lifesciences Identifier: NCT01238835     History of Changes
Other Study ID Numbers: 2009-06
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Edwards Lifesciences:
Sapien XT Valve
Valvular Heart Disease
Aortic Stenosis
Heart Valve Therapy

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction