Trials / Active Not Recruiting
Active Not RecruitingNCT04198870
MitraClip REPAIR MR Study
Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery (REPAIR MR)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MitraClip™ device implantation | Transcatheter repair of the mitral valve using MitraClip™ device |
| PROCEDURE | Mitral Valve Repair Surgery | Surgical repair of the mitral valve |
Timeline
- Start date
- 2020-07-21
- Primary completion
- 2027-12-01
- Completion
- 2035-12-01
- First posted
- 2019-12-13
- Last updated
- 2025-11-12
Locations
74 sites across 4 countries: United States, Canada, Germany, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04198870. Inclusion in this directory is not an endorsement.