Trials / Active Not Recruiting
Active Not RecruitingNCT04375332
Beating Heart Mitral Valve Repair With the HARPOON™ System
A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
Detailed description
RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HARPOON™ Beating Heart Mitral Valve Repair System | Repair of the chordae tendinae in the mitral valve. |
Timeline
- Start date
- 2020-12-16
- Primary completion
- 2027-12-20
- Completion
- 2027-12-20
- First posted
- 2020-05-05
- Last updated
- 2025-08-26
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04375332. Inclusion in this directory is not an endorsement.