CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.

CompletedOBSERVATIONAL
Enrollment

202

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

November 30, 2017

Study Completion Date

December 3, 2018

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

CoreValve Transcatheter Valve

Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.

Trial Locations (25)

Unknown

CHU Brest, Brest

CHU Clermont, Clermont-Ferrand

CHU Mondor, Créteil

Clinique Parly 2 Le Chesnay, Le Chesnay

CHU Lille, Lille

HCL CHU Louis Pradel, Lyon

CHU La Timone, Marseille

Hopital Jacques Cartier, Massy

CHU de Nantes, Nantes

CHU La Pitié Salpétrière, Paris

CHU Bordeaux, Pessac

CHU Rennes, Rennes

CHU Rangueil Toulouse, Toulouse

Clinique Pasteur, Toulouse

Tonkin Clinic, Villeurbanne

Kerckhoff Klinik, Bad Nauheim

Herz- und Diabeteszentrum NRW, Bad Oeynhausen

Sana-Herzzentrum Cottbus, Cottbus

Hamburg Eppendorf, Hamburg

Herzzentrum Leipzig GmbH Leipzig, Leipzig

Rabin Medical center, Petah Tikva

Sheba Medical Center, Tel Litwinsky

Brescia Hospital, Brescia

Policlinico San Donato, Milan

Azienda Ospedaliero Universitaria Pisana, Pisa

All Listed Sponsors
lead

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

NCT02209298 - CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. | Biotech Hunter | Biotech Hunter