Status:
RECRUITING
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
Lead Sponsor:
Half Moon Medical
Conditions:
Mitral Valve Insufficiency
Eligibility:
All Genders
21-95 years
Phase:
NA
Brief 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, symptom...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04343313
Start Date
December 8 2020
End Date
December 31 2029
Last Update
January 12 2024
Active Locations (5)
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1
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, United States, 10032
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
3
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
4
Oregon Health & Science University
Portland, Oregon, United States, 97239