NCT01808287 - Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study | Biotech Hunter

Enrollment

250

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 31, 2013

Study Completion Date

December 17, 2019

Conditions

Aortic Valve Disease

Interventions

DEVICE

Edwards SAPIEN 3 Transcatheter Heart Valve

The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Trial Locations (17)

20251

Universitares Herzzentrum Hamburg GmbH, Hamburg

31059

CHU Rangueil, Toulouse

35128

Policlinico Universitario, Padua

45122

Universitatsklinik Essen, Essen

50937

Universitatsklinik Koln, Cologne

61231

Kerckhoff Heartcenter, Bad Nauheim

75018

Paris, Hopital Bichat, Paris

76031

CHU Charles Nicolle, Rouen

76133

Stadtisches Klinikum Kalsruhe, Karlsruhe

91300

Massy, Institut Jacques Cartier, Massy

V6Z 1 Y6

St. Paul's Hospital, Vancouver

G1V4G5

Laval, Institut universitaire de cardiologie et de pneumologie de Quebec, Laval

BT12 6BA

Royal Victoria Hospital, Belfast

SE1 7EH

London St. Thomas's Hospital, London

SE5 9RS

King's College Hospital, London

W1G 8PH

Barts Health NHS Trust Hospital, London

PL6 8DH

Derriford Hospital, Plymouth