Trials / Unknown
UnknownNCT03997305
AltaValve Early Feasibility Study Protocol
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- 4C Medical Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
Conditions
- Mitral Regurgitation
- Mitral Insufficiency
- Mitral Valve Incompetence
- Mitral Valve Regurgitation
- Mitral Incompetence
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AltaValve | Transcatheter Mitral Valve Replacement |
Timeline
- Start date
- 2019-12-04
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
- First posted
- 2019-06-25
- Last updated
- 2023-09-01
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03997305. Inclusion in this directory is not an endorsement.