Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

Study Overview
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Brief Summary
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PILOT: The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high risk mitral regurgitation patients. EFS: The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe, Symptomatic Mitral Regurgitation

Detailed Description
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PILOT: The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high-risk patients with severe, symptomatic mitral regurgitation, who are deemed ineligible for standard surgery. EFS: The study is a multi-center, prospective, non-randomized, trial to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe, Symptomatic Mitral Regurgitation

Official Title
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An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Device: Twelve TMVR Implant
* Device: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Severe mitral regurgitation (MR Grade 3-4+) Symptomatic mitral regurgitation (NYHA Class II-IV) Trans-apical access deemed feasible by the treating physician (PILOT only) Subjects anatomically suitable for the Intrepid TMVR delivery system including transfemoral and transseptal access (EFS only) Native mitral valve geometry and size compatible with the Twelve TMVR/Intrepid Key Exclusion Criteria: Left ventricular ejection fraction (LVEF) < 20 (PILOT) or <25% (EFS) Evidence of intracardiac mass, thrombus, or vegetation Prior valve surgery or need for other valve surgery Prior stroke within 4 weeks (PILOT) or 90 days (EFS) Prior myocardial infarction within 6 months (PILOT) or 90 days (EFS) Need for coronary revascularization History of, or active, endocarditis Renal insufficiency (Creatinine > 2.5 mg/dL)

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Mitral Valve Replacement (TMVR) Implant<br>Twelve TMVR Implant | Device: Twelve TMVR Implant<br>* Implantation of the Twelve TMVR System -Apical<br>* Other names: Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System;Device: Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System<br>* Implant of Intrepid valve -Transfemoral<br>* Other names: Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of patients with adverse events associated with the delivery and/or implantation of the device | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success (Number of patients with successful TMVR placement) | Number of patients with successful TMVR placement | Through 5 years | 
| Reduction of MR (Number of patients with a reduction of MR Grade) | Number of patients with a reduction of MR Grade | Through 5 years |