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Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) — ACTIVE  

Mitral Regurgitation Clinical Trial

Official title:
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 GDMT vs GDMT Alone in Patients With FMR and Heart Failure

Clinical Trial Summary

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03016975
Study type Interventional
Source Edwards Lifesciences
Contact
Status Terminated
Phase N/A
Start date June 1, 2017
Completion date September 20, 2022
View Details
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