The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

Study Overview
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Brief Summary
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The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

Official Title
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Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Device: Half Moon TMVr System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+) Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies Age ≥ 21 Native mitral valve geometry and size compatible with the Half Moon TMVr implant Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits Key Exclusion Criteria: Prior transseptal intervention with occlusion device currently implanted Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation Prohibitive mitral annular or leaflet calcification Diseased mitral anterior leaflet such as flail or prolapse Left ventricular ejection fraction (LVEF) < 25%, or LVEF 25-30% in the presence of left ventricular end diastolic volume index (LVEDVi) >120mL/m2 as measured by resting echocardiogram within 30 days of the Index Procedure Left ventricular end diastolic diameter (LVEDD) > 75mm Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction Severe tricuspid regurgitation Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment Prior stroke, TIA, or myocardial infarction within 90 days Need for coronary revascularization Severe symptomatic carotid artery stenosis Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc Need for emergent surgery Endocarditis within 6 months Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment GI bleeding within 6 months History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support Platelet count of <75,000 cells/mm3 Renal insufficiency (Creatinine > 2.5 mg/dL) Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics) Contraindication to transesophageal echocardiography (TEE) Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment) Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 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: Half Moon TMVr System<br>The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve. | Device: Half Moon TMVr System<br>* The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Placement | Assessment of the ability to accurately deliver and place the implant within the native anatomy | 30 Days (+ annually through 5 years) | 
| Device Performance | The degree of improvement of MR grade | 30 Days (+ annually through 5 years) | 
| Symptom Improvement | The degree of improvement of MR symptoms | 30 Days (+ annually through 5 years) | 
| Device Durability | The durability of TMVr function | 30 Days (+ annually through 5 years) |