Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Functional Mitral Regurgitation
- Mitral Insufficiency
- Mitral Regurgitation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03016975
- Collaborators
- Not Provided
- Investigators
- Study Chair: Mark Reisman, MD University of Washington Principal Investigator: Brian Whisenant, MD Intermountain Medical Center Principal Investigator: Vinod Thourani, MD Medstar Washington Hospital Center
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