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Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE) Trial: Transcatheter Mitral Valve Repair With Edwards Cardioband System and GDMT vs GDMT Alone in Patients With FMR and Heart Failure (NCT03016975)

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
  • Device: Edwards Cardioband System
    Transcatheter mitral valve repair with the Edwards Cardioband System
    • Transcatheter mitral valve repair (TMVr)
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Inclusion Criteria:
  • Age > 18 years;
  • Clinically Significant Functional Mitral Regurgitation (MR);
  • NYHA Class II-IV;
  • Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);
  • Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance.
Exclusion Criteria:
  • Degenerative MR including mixed degenerative/functional MR;
  • Severe mitral annular calcification;
  • Other severe valve disorders requiring intervention according to current ACC/AHA valve guidelines;
  • Mitral valve anatomy which may preclude proper Edwards Cardioband deployment;
  • Life expectancy of less than twelve months;
  • Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint;
  • Unwillingness or inability to undergo follow-up investigations/visits;
  • Other medical, social, or psychological conditions that precludes appropriate consent and follow-up
The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

7 locations

United States (7)
  • MedStar Washington Hospital Center
    Washington, District of Columbia, United States, 20010
  • Columbia University Medical Center/New York Presbyterian Hospital
    New York, New York, United States, 10032
  • St. Francis Hospital
    Roslyn, New York, United States, 11576
  • Pinnacle Health
    Harrisburg, Pennsylvania, United States, 17101
  • The University of Texas Health Science Center at Houston
    Houston, Texas, United States, 77030
  • The Heart Hospital Baylor Plano
    Plano, Texas, United States, 75093
  • Intermountain Medical Center
    Murray, Utah, United States, 84107
31 May, 2017
06 November, 2017
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