RecruitingNot ApplicableNCT04343313

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

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

Sponsor

Half Moon Medical

Enrollment

30 participants

Start Date

Dec 8, 2020

Study Type

INTERVENTIONAL

Conditions

Mitral Valve Insufficiency

Summary

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.

Eligibility

Min Age: 21 YearsMax Age: 95 Years

Inclusion Criteria7

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

Exclusion Criteria29

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

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Interventions

DEVICEHalf Moon TMVr System

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.