NCT02458560 - CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve | Biotech Hunter

Enrollment

203

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

August 22, 2016

Study Completion Date

August 13, 2021

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 (27)

1023

Auckland City Hospital, Grafton

1105

Academisch Medisch Centrum (AMC), Amsterdam

2100

Rigshospitalet, Copenhagen

3010

Inselspital Bern, Bern

3015

Erasmus University Medical Center Rotterdam, Rotterdam

3121

Epworth Healthcare, Melbourne

3584

Universitair Medical Center (UMC) Utrecht, Utrecht

4032

The Prince Charles Hospital, Brisbane

5000

Royal Adelaide Hospital, Adelaide

10117

Charité - Universitaetsmedizin Berlin, Berlin

20099

Asklepios Klinik St Georg, Hamburg

20132

Ospedale San Raffaele s.r.l., Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

23795

Segeberger Kliniken GmbH, Bad Segeberg

31300

Clinique Pasteur, Toulouse

35033

CHU Pontchaillou, Rennes

48149

Universitaetsklinikum Muenster, Münster

53105

Herzzentrum Universitaet Bonn, Bonn

56124

Azienda Ospedaliero-Universitaria Pisana, Pisa

76133

Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH, Karlsruhe

80636

Deutsches Herzzentrum Muenchen, Munich

81377

LMU - Klinikum der Universitaet Muenchen, Munich

86156

Klinikum Augsburg, Augsburg

91300

Institut Hospitalier Jacques Cartier, Massy

95124

Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania, Catania

04289

Herzzentrum Leipzig GmbH, Leipzig

BT12 6BA

Royal Victoria Hospital, Belfast