Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.

NACompletedINTERVENTIONAL
Enrollment

739

Participants

Timeline

Start Date

February 8, 2017

Primary Completion Date

May 2, 2019

Study Completion Date

February 16, 2022

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

Symetis ACURATE neo/TF transfemoral TAVI system

Transcatheter aortic valve implantation of a Symetis ACURATE neo/TF bioprosthesis by transfemoral access, pre-dilatation mandatory.

DEVICE

Edwards Sapien 3 Transcatheter Heart Valve

Transcatheter aortic valve implantation of an Edwards Sapien 3 bioprosthesis by transfemoral access.

Trial Locations (20)

3010

Bern University Hospital, Bern

6000

Luzerner Kantonsspital, Lucerne

8091

Universitätsspital Zürich, Zurich

20251

Universitäres Herzzentrum Hamburg GmbH, Hamburg

29549

Herz- und Gefässzentrum Bad Beversen, Bad Bevensen

44137

St.-Johannes-Hospital, Dortmund

50931

Herzzentrum Uniklinik Köln, Cologne

61231

Kerckhoff-Klinik, Bad Nauheim

76133

Städtisches Klinikum Karlsruhe, Karlsruhe

76135

ViDia Kliniken, Karlsruhe

76185

Klinik für Herzchirurgie Karlsruhe, Karlsruhe

80636

Deutsches Herzzentrum München, München

86156

Klinkum Augsburg, Augsburg

93053

Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Regensburg

97616

Herz- und Gefäss-Klinik GmbH Bad Neustadt, Bad Neustadt an der Saale

99437

Zentralklinik Bad Berka, Bad Berka

01307

Herzzentrum Dresden, Dresden

04289

Herzzentrum Leipzig, Leipzig

3584 CX

University Medical Center Utrecht, Utrecht

SE1 7EH

St Thomas' Hospital, London

All Listed Sponsors
lead

Insel Gruppe AG, University Hospital Bern

OTHER

NCT03011346 - Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis. | Biotech Hunter | Biotech Hunter