ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe

CompletedOBSERVATIONAL
Enrollment

721

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

June 30, 2012

Study Completion Date

August 31, 2012

Conditions
Mitral Valve (MV) Regurgitation
Interventions
DEVICE

MitraClip

The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets

DRUG

Medical Management

The Non-Surgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed non-surgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included

PROCEDURE

Mitral Valve Surgery

The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.

Trial Locations (1)

37075

Universitatsmedizin Gottingen, Göttingen

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY