Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve

NACompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 1, 2013

Primary Completion Date

September 17, 2013

Study Completion Date

August 23, 2018

Conditions
Aortic Valve Disease
Interventions
DEVICE

Edwards CENTERA Self-Expanding Transcatheter Heart Valve

The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Trial Locations (4)

3010

Inselspital Bern, Bern

20099

Asklepios Klinik St Georg Hamburg, Hamburg

53127

Herzzentrum Universitaet Bonn, Bonn

042 89

Heart Center Leipzig, Leipzig

Sponsors
All Listed Sponsors
collaborator

Medstar Health Research Institute

OTHER

collaborator

European Cardiovascular Research Center

NETWORK

collaborator

University of British Columbia

OTHER

lead

Edwards Lifesciences

INDUSTRY