Trials / Terminated
TerminatedNCT04393779
Observational Registry on the HARPOON Device
Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
Detailed description
This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HARPOON Beating Heart Mitral Valve Repair System (MVRS) | Repair of the chordae tendinae in the mitral valve. |
Timeline
- Start date
- 2020-10-02
- Primary completion
- 2022-11-17
- Completion
- 2022-11-17
- First posted
- 2020-05-19
- Last updated
- 2024-01-29
- Results posted
- 2024-01-29
Locations
7 sites across 3 countries: Germany, Spain, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04393779. Inclusion in this directory is not an endorsement.