An interventional study of Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) and Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) in Mitral Valve Regurgitation, sponsored by Medtronic Cardiovascular. Recruiting at 85 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Medtronic Cardiovascular · Not applicable, Interventional, and Treatment
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Exclusion Criteria:
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
mitral valve replacement
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Primary Cohort
Composite of all-cause mortality or heart failure hospitalization
Time frame: 1 year
MAC Cohort
All-cause mortality
Time frame: 1 year
All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding
Composite
Time frame: 30 days or hospital discharge (whichever is later)
Degree of mitral regurgitation
measured by echocardiography
Time frame: 6 months
Quality of Life Improvement
measured by KCCQ
Time frame: 3 months (KCCQ)
Change in New York Heart Association Class
change in NYHA Class
Time frame: 30 days
Echocardiographic assessments of degree mitral valve regurgitation
measured by echocardiography
Time frame: 1 year
Cardiovascular hospitalizations
cardiovascular hospitalizations
Time frame: 1 year
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Medtronic Cardiovascular