Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II

CompletedOBSERVATIONAL
Enrollment

796

Participants

Timeline

Start Date

April 20, 2017

Primary Completion Date

June 4, 2020

Study Completion Date

June 4, 2020

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

Symetis ACURATE neo™ transfemoral TAVI system

Symetis ACURATE neo™ transfemoral TAVI system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to mitigate paravalvular regurgitation (manufactured by Symetis SA, Ecublens, Switzerland).

DEVICE

Medtronic CoreValve Evolut R TAVI System

Medtronic CoreValve Evolut R Transcatheter Aortic Valve Implantation (TAVI) System (or any future CE-marked Corevalve versions): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).

Trial Locations (23)

13353

Deutsches Herzzentrum Berlin, Berlin

15706

Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela

16321

Herzzentrum Brandenburg, Immanuel Klinikum Bernau, Bernau bei Berlin

20089

Istituto Clinico Humanitas, Rozzano- (MI)

20097

IRCCS Policlinico San Donato, San Donato

20132

Ospedale San Raffaele, San Raffaele

29200

CHRU Brest Cavale Blanche, Brest

31076

Clinique Pasteur, Toulouse

32545

Herz- und Diabeteszentrum NRW, Bad Oeynhausen

44137

St.-Johannes-Hospital, Dortmund

45138

Elisabeth-Krankenhaus Essen, Essen

52074

University Hospital Aachen, Aachen

59037

Centre Hospitalier Universitaire de Lille, Lille

60323

Goethe-University Frankfurt, Frankfurt

80636

Deutsches Herzzentrum München des Freistaates Bayern, Munich

Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München, Munich

91300

Hôpital Jacques Cartier, Massy

95124

University of Catania, Ferrarotto Hospital, Catania

DK-2100

Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen

01307

Technische Universität Dresden, Dresden

04289

Herzzentrum Leipzig - Universitätsklinik, Leipzig

BN25BE

Brighton and sussex University hospital NHS trust, Brighton

Unknown

The Leeds Teaching Hospitals NHS TRUST, Leeds

All Listed Sponsors
collaborator

Symetis SA

INDUSTRY

lead

Ceric Sàrl

INDUSTRY

NCT03192813 - Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II | Biotech Hunter | Biotech Hunter