Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Study Overview
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Brief Summary
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Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Official Title
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Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
* Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)


Participation Criteria
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Eligibility Criteria
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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 <30% need for emergent or urgent surgery hemodynamic instability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Cohort- TMVR<br>Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) | Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)<br>* mitral valve replacement<br>Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)<br>* Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement<br>|
| Experimental: Mitral Annular Calcification -TMVR<br>Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) | Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)<br>* mitral valve replacement<br>Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)<br>* Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Cohort | all-cause mortality or heart failure hospitalization post-30 days or KCCQ improvement < 10 composite | 1 year | 
| MAC Cohort | all-cause mortality | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding | Composite | 30 days or hospital discharge (whichever is later) | 
| Change in New York Heart Association Class | change in NYHA Class | 30 days | 
| Quality of Life Improvement | measured by SF-12 and KCCQ | 30 days (SF-12) and 3 months (KCCQ) | 
| Echocardiographic assessments of degree mitral valve regurgitation | measured by echocardiography | 1 year | 
| Cardiovascular hospitalizations | cardiovascular hospitalizations | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart disease, valve disease, heart valve disease, mitral regurgitation, cardiovascular disease, mitral insufficiency