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Primary Diagnosis

Mitral Valve Disease

​Study Purpose

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.

Principal Investigator: Robert L. Smith, II, MD

​Trial Details

Locations: Baylor Scott & White The Heart Hospital – Plano

Sponsor: Edwards Lifesciences

IRB Number: 017-150

Trial Status: Enrolling

Exclusions: Adults only

Change in Care: Participating may change your care

Contact Information:

Brittany Zingler, RN

Necole Kell, RN

Full Protocol Title

Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

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