Trials / Completed
CompletedNCT00120276
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- Myocor · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.
Detailed description
Patient clinical evaluations will consist of 3-month, 6-month, and 12-month follow up of the primary endpoints. Additional follow up of 18-month, 24-month, and annually thereafter will also be included.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Less invasive mitral valve repair |
Timeline
- Start date
- 2004-06-01
- First posted
- 2005-07-15
- Last updated
- 2009-05-07
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00120276. Inclusion in this directory is not an endorsement.