Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

PHASE3CompletedINTERVENTIONAL
Enrollment

803

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Severe Aortic StenosisTranscatheter Aortic Valve ReplacementAortic Valve Replacement
Interventions
DRUG

Bivalirudin

Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.

DRUG

Unfractionated Heparin

Unfractionated heparin is an anticoagulant.

Trial Locations (33)

3010

Universitätsklinik Bern, Bern

3435

St. Antonius Ziekenhuis, Nieuwegein

20099

Asklepios St. Georg Hamburg, Hamburg

20132

Ospedale San Raffaele U.O. Cardiologia Interventistica, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

25000

CHU Jean Minjoz, Service de Cardiologie, Besançon

28277

Klinikum links der Weser Bremen, Bremen

30625

Medizinische Hochschule Hannover, Hanover

31059

CHU de Toulouse, Toulouse

31076

Clinique Pasteur, Unité de Cardiologie Interventionnelle, Toulouse

45257

Elisabeth-Krankenhaus Essen, Essen

53105

Universitätsklinikum Bonn, Bonn

53721

Helios Heart Center Siegburg, Siegburg

55131

Universitätsmedizin der Johannes Gutenberg-Universitat Mainz, Mainz

56124

Azienda Ospedaliero-Universitaria Pisana, Pisa

59037

Department of Cardiology, CHRU Lille, Lille

69500

Centre Hospitalier de Lyon, Bron

76031

Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle, Rouen

79106

Freiburg University, Freiburg im Breisgau

80636

Deutsches Herzzentrum München, München

81377

LMU Munich, Klinikum der Universität München, Munich

91300

Institut Hospitalier Jacques Cartier, Massy

95123

Ferraroto Hospital, University of Catania, Catania

H1T 1C8

Montreal Heart Institute, Montreal

V6Z1Y6

St. Paul´s Hospital Providence Health Care, Vancouver

07747

University Heart Centre, Clinic of Inner Medicine 1 Cardiology, Jena

04289

Universität Leipzig - Herzzentrum GmbH, Leipzig

00151

Azienda Ospedaliera San Camillo-Forlanini, Roma

Unknown

Policlinico Umberto I, Università La Sapienza, Roma

3584 CX

University Medical Center Utrecht, Utrecht

CH-4031

Cardiology University Hospital Basel, Basel

BN2 5BE

The Royal Sussex County Hospital, Brighton

W12 0HS

Hammersmith Hospital, London

Sponsors
All Listed Sponsors
lead

The Medicines Company

INDUSTRY