Trials / Active Not Recruiting
Active Not RecruitingNCT03230747
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
Detailed description
Prospective, single-arm, multicenter early feasibility study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards SAPIEN M3 System | SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock |
Timeline
- Start date
- 2017-09-14
- Primary completion
- 2021-06-16
- Completion
- 2027-08-01
- First posted
- 2017-07-26
- Last updated
- 2025-07-22
Locations
9 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03230747. Inclusion in this directory is not an endorsement.