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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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Page 1 of 2 (5 locations)

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