Trials / Terminated
TerminatedNCT04382612
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
Detailed description
This trial is a single arm, prospective, multi-center, non-randomized and open-label post-market study 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
- 2022-11-14
- Completion
- 2022-12-01
- First posted
- 2020-05-11
- Last updated
- 2023-12-22
- Results posted
- 2023-12-22
Locations
10 sites across 4 countries: Austria, Germany, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04382612. Inclusion in this directory is not an endorsement.