Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Detailed Description
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Prospective, single-arm, multi-center, interventional, pre-market trial

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

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: Medtronic Intrepid™ TMVR TF System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Subject meets the legal minimum age to provide informed consent based on local regulatory requirements Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System Exclusion Criteria: Estimated life expectancy of less than 24 months Currently surgically implanted mitral valve Prior transcatheter mitral valve procedure with device currently implanted Anatomic contraindications Anatomically prohibitive mitral annular calcification (MAC) Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - <30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function) Left ventricular end diastolic diameter (LVEDD) > 75mm Need for emergent or urgent surgery Hemodynamic instability History of bleeding diathesis or coagulopathy End stage renal disease Liver failure Frailty

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
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects with moderate-to-severe or severe symptomatic mitral regurgitation who by agreement of the heart team experienced in mitral valve therapies are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medtronic Intrepid™ TMVR TF System<br>Medtronic Intrepid™ TMVR TF System | Device: Medtronic Intrepid™ TMVR TF System<br>* Patients with moderate-to-severe or severe symptomatic mitral regurgitation will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: all-cause mortality at 1-year post-procedure. | Rate of all-cause mortality at 1-year post-procedure. | 1 year | 
| Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure. | Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality (Safety). | Rate of all-cause mortality at 30 days post-procedure. | 30 days | 
| Disabling stroke (Safety). | Rate of disabling stroke at 30 days post-procedure. | 30 days | 
| Acute Kidney Injury (stage 3 or with renal replacement) (Safety). | Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure. | 30 days | 
| Reoperation or reintervention (Safety). | Rate of reoperation or reintervention at 30 days post-procedure. | 30 days | 
| Major access site vascular complications (Safety). | Number of major access site vascular complications at 30 days post-procedure. | 30 days | 
| Mitral valve regurgitation (Efficacy). | Degree of mitral valve regurgitation at 1 year as assessed by the Echocardiography Core Laboratory. | 1 year | 
| NYHA functional class (Efficacy). | Change in NYHA functional class at 1 year (Efficacy). | 1 year | 
| Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy). | Change of Quality of Life (QoL) at 1 year as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores are scaled from 0 to 100, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. | 1 year | 
| Cardiovascular hospitalizations (Efficacy). | Cardiovascular hospitalizations through 1 year (Efficacy). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral, valve, regurgitation, TMVR, Intrepid™, symptomatic, severe