Trials / Completed
CompletedNCT03539458
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
Conditions
- Mitral Regurgitation
- Mitral Insufficiency
- Mitral Annular Calcification
- Mitral Annulus Calcification
- Cardiovascular Diseases
- Valve Heart Disease
- Heart Valve Diseases
- Heart Valve Calcification
- Mitral Valve Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tendyne Mitral Valve System | Mitral valve replacement |
Timeline
- Start date
- 2018-10-10
- Primary completion
- 2019-11-29
- Completion
- 2024-06-18
- First posted
- 2018-05-29
- Last updated
- 2024-11-18
- Results posted
- 2021-01-26
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03539458. Inclusion in this directory is not an endorsement.