Status:
RECRUITING
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2036
Estimated Enrollment :
1056 Patients enrolled
Trial Details
Trial ID
NCT03242642
Start Date
October 23 2017
End Date
September 30 2036
Last Update
January 6 2026
Active Locations (85)
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1
University of Alabama Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35233
2
Abrazo Heart Hospital
Phoenix, Arizona, United States, 85018
3
Scripps Memorial Hospital
La Jolla, California, United States, 92037
4
PIH Health Good Samaritan Hospital
Los Angeles, California, United States, 90017