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

NCT01288976 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 721

Last updated 2018-11-07

Study results available
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Summary

The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Barathi Sethuraman, PhD · Abbott Vascular Structural Heart (Evalve Inc)

  • Wolfgang Schillinger, MD · Universitatsmedizin Gottingen

  • Francesco Maisano, MD · Fondazion Ctr San Raffaele Del Monte Tabor Istituto

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288976 on ClinicalTrials.gov