Trials / Terminated
TerminatedNCT03016975
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards Cardioband System | Transcatheter mitral valve repair with the Edwards Cardioband System |
| DRUG | Guideline Directed Medical Therapy | GDMT Only |
Timeline
- Start date
- 2017-06-01
- Primary completion
- 2019-07-19
- Completion
- 2022-09-20
- First posted
- 2017-01-11
- Last updated
- 2023-11-30
- Results posted
- 2022-11-09
Locations
24 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03016975. Inclusion in this directory is not an endorsement.