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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 21 Years and 95 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+) 2. Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team 3. 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 4. Age ≥ 21 5. Native mitral valve geometry and size compatible with the Half Moon TMVr implant 6. Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System 7. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits

Exclusion Criteria

  1. Prior transseptal intervention with occlusion device currently implanted 2. 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 3. Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation 4. Prohibitive mitral annular or leaflet calcification 5. Diseased mitral anterior leaflet such as flail or prolapse 6. 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 7. Left ventricular end diastolic diameter (LVEDD) > 75mm 8. Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure 9. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction 10. Severe tricuspid regurgitation 11. Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure 12. Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment 13. Prior stroke, TIA, or myocardial infarction within 90 days 14. Need for coronary revascularization 15. Severe symptomatic carotid artery stenosis 16. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc 17. Need for emergent surgery 18. Endocarditis within 6 months 19. Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment 20. GI bleeding within 6 months 21. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion 22. Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support 23. Platelet count of <75,000 cells/mm3 24. Renal insufficiency (Creatinine > 2.5 mg/dL) 25. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics) 26. Contraindication to transesophageal echocardiography (TEE) 27. Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically 28. Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment) 29. Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Half 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.
  • Device: Half 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.

Recruiting Locations

Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York 10032
Contact:
Susheel Kodali, MD
sk2427@cumc.columbia.edu

Montefiore Medical Center
The Bronx, New York 10467
Contact:
Azeem Latib, MD

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
Guilherme Attizzani, MD

Oregon Health & Science University
Portland, Oregon 97239
Contact:
Firas Zahr, MD

UPMC Heart & Vascular Institute
Harrisburg, Pennsylvania 17104
Contact:
Hemal Gada, MD

More Details

Status
Recruiting
Sponsor
Half Moon Medical

Study Contact

Craig Straley
4153109197
craigstraley.halfmoon@gmail.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.