Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients

Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients
Recruiting
1 years - 99 years
All
Phase 4
25 participants needed

Brief description of study

This is a study of the MitraClip, percutaneous mitral valve repair system in patients with moderate to severe to severe functional mitral regurgitation who need surgical repair but are deemed not appropriate for surgery. Patients will be randomized in a 1:1 fashion to treatment with the Mitra Clip system or medical management. Patients will be followed by the investigators at 30 days, 6, 12, 18, 24 months and then yearly for up to five years with office visits and echocardiograms. Patients who randomize to medical management can crossover to the treatment arm after 24 months of follow up.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mitral Valve Insufficiency, mitral valve insufficiency
  • Age: 1 years - 99 years
  • Gender: All
Updated on 19 Feb 2024. Study ID: 815740

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