CARDIOBAND Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A prospective, multicenter, randomized, controlled pivotal trial to assess transcatheter mitral valve repair with Edwards Cardioband System and guideline directed medical therapy (GDMT) compared to GDMT alone inpatients with functional mitral regurgitation (FMR) and heart failure. (Protocol Number: 201705).
Edwards Cardioband System & medical therapy versus medical therapy alone in patients with functional mitral regurgitation and heart failure
Sponsor: Edwards
Enrolling: Male and Female Patients
IRB Number: AAAR4721
U.S. Govt. ID: NCT03016975
Contact: Lauren Privitera: 212-342-3488 /
Additional Study Information: The purpose of this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study is expected to take approximately 5 years to complete if you are eligible. You will need to return to your doctors office at 1 month, 6 months, and 1, 2, 3, 4 and 5 years after the device implant procedure. Once you have completed the 5-year follow up, your participation in the study is complete.
This study is closed
Susheel Kodali, MD
Do You Qualify?
Are you 18 years or older? Yes No
Do you have mitral regurgitation? Yes No
You may be eligible for this study

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For more information, please contact:
Lauren Privitera