SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

Study Overview
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Brief Summary
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This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.

Detailed Description
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Prospective, single-arm, multicenter early feasibility study

Official Title
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Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation

Conditions
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Mitral Regurgitation, Mitral Disease

Intervention / Treatment
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* Device: Edwards SAPIEN M3 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older MR ≥ 3+ NYHA functional class ≥ II High risk of cardiovascular surgery Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve Cardiac imaging evidence of intracardiac mass, thrombus or vegetation Significant risk of LVOT obstruction Severe right ventricular dysfunction LV Ejection Fraction <30% Patient is inoperable Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment Need for aortic, tricuspid or pulmonic valve replacement Presence of mechanical aortic valve prosthesis History of cardiac transplantation History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism Clinically significant untreated coronary artery disease requiring revascularization Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days. Stroke or transient ischemic attack within 90 days of the procedure Myocardial infarction within 30 days of the procedure Active bacterial endocarditis within 180 days of the procedure Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days. Irreversible, severe pulmonary hypertension Patients with renal insufficiency or receiving renal replacement therapy Liver disease or significantly abnormal liver function test results Refusal of blood products Female who is pregnant or lactating Estimated life expectancy < 12 months Participating in another investigational drug or device study

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMVR<br>Subjects will undergo transcatheter mitral valve replacement | Device: Edwards SAPIEN M3 System<br>* SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Defined as meeting all the following: Alive Successful access, delivery and retrieval of the delivery systems Deployment of the devices in the intended position Freedom from emergency surgery or reintervention related to the device or access procedure | At the end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in mitral regurgitation (MR) | Reduction in MR to 0 or 1+ | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Mitral Valve Replacement, SAPIEN M3