Trials / Recruiting
RecruitingNCT06465745
AltaValve Pivotal Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- 4C Medical Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
Conditions
- Mitral Regurgitation
- Mitral Insufficiency
- Mitral Valve Incompetence
- Mitral Valve Regurgitation
- Mitral Incompetence
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AltaValve System. | Transcatheter Mitral Valve Replacement. |
Timeline
- Start date
- 2024-09-03
- Primary completion
- 2029-09-01
- Completion
- 2031-09-01
- First posted
- 2024-06-20
- Last updated
- 2025-05-02
Locations
29 sites across 4 countries: United States, Germany, Greece, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06465745. Inclusion in this directory is not an endorsement.