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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01238835
First received: January 26, 2010
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
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 Intervention
Aortic Valve Stenosis
Device: SAPIEN XT™ Transapical aortic valve replacement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

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

Secondary Outcome Measures:
  • 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

  • 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


Enrollment: 218
Actual Study Start Date: September 2009
Study Completion Date: March 2016
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238835

Locations
Austria
Medizinische Universitat Wien Univ.Klinik f.Chirurgie
Wien, Austria, 1019
France
Hôspital Bichat
Paris, France, 75018
Germany
Herz-Und Gefasszentrum Bad Bevensen
Bad Bevensen, Germany, 29549
Kerckhoff-Klinik
Bad Nauheim, Germany, 61231
Herz-und-Gefass Klinik
Bad Neustadt, Germany, 97616
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
Schüchtermann-Klinik
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
Robert-Bosch-Krankenhaus
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
Investigators
Principal Investigator: Prof. Dr. Thomas Walther Kerckhoff Klinik
Principal Investigator: Dr. Olaf Wendler King's College London
  More Information

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01238835     History of Changes
Other Study ID Numbers: 2009-06
Study First Received: January 26, 2010
Last Updated: February 7, 2017
Individual Participant Data  
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
Transapical
Transcatheter

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

ClinicalTrials.gov processed this record on May 25, 2017