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NCT01238835 Clinical Trial

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

Aortic Valve Stenosis Clinical Trial

Official title:
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01238835
Other study ID # 2009-06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date March 2016

Study information
Verified date October 2020
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date March 2016
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• SAPIEN XT™ Transapical aortic valve replacement
Transcatheter aortic valve implantation via the transapical approach

Locations
Country Name City State
Austria Medizinische Universitat Wien Univ.Klinik f.Chirurgie Wien
France Hôspital Bichat Paris
Germany Herz-Und Gefasszentrum Bad Bevensen Bad Bevensen
Germany Kerckhoff-Klinik Bad Nauheim
Germany Herz-und-Gefass Klinik Bad Neustadt An Der Saale
Germany Herz-und Diabeteszentrum NRW Bad Oeynhausen
Germany Schüchtermann-Klinik Bad Rothenfelde
Germany Heart Center University Cologne Cologne
Germany Herzzentrum Dresden GmbH Dresden
Germany University Clinic Erlangen Erlangen
Germany University Hospital Essen, West German Heart Center Essen
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Cardiac Surgery Karlsruhe Karlsruhe
Germany Heart Center Leipzig Leipzig
Germany German Heart Center Munich Munich
Germany Hospital Munich-Bogenhausen Munich
Germany University Hospital Munich-Grosshadern Munich
Germany Robert-Bosch-Krankenhaus Stuttgart
United Kingdom King's College Hospital London
United Kingdom St. Thomas' Hospital - NHS Trust London

Sponsors (1)
Lead Sponsor Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  France,  Germany,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Deaths Number of death at 30-days from the index procedure. 30 days
Secondary Number of Participants With a Stroke Total Number of Participants with a Stroke. 30-days
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