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Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery

NCT01431222 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-09-09

No results posted yet for this study

Summary

The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

percutaneous treatment by implanting a Mitra Clip device

With a minimal-invasive, percutaneous catheter-based technique and trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance, the MitraClip device grasps and approximates the mitral leaflets thus creating a double-orifice mitral valve with a permanent leaflet coaptation and a reduction or even abrogation of mitral regurgitation.

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Joerg Hausleiter, MD · Deutsches Herzzentrum Muenchen

  • Steffen Massberg, MD · Deutsches Herzzentrum Muenchen

  • Juergen Pache, MD · Deutsches Herzzentrum Muenchen

  • Hasema Lesevic, MD · Deutsches Herzzentrum Muenchen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2014-09-30

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 NCT01431222 on ClinicalTrials.gov