Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Purpose
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Condition
- Mitral Valve Regurgitation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Moderate to severe or severe symptomatic mitral regurgitation - Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
Exclusion Criteria
- prior transcatheter mitral valve procedure with device currently implanted - anatomic contraindications - prohibitive mitral annular calcification - left ventricular ejection fraction <25% - need for emergent or urgent surgery - hemodynamic instability
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Primary Cohort- TMVR |
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) |
|
|
Experimental Mitral Annular Calcification -TMVR |
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) |
|
Recruiting Locations
University of Alabama Birmingham (UAB)
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Cardiovascular