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

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