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The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT04343313•Half Moon Medical

View on ClinicalTrials.gov

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

Age

21 - 95 years

Sex

ALL

Healthy Volunteers

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
+19 more criteria

Locations (5)

Columbia University Medical Center/NewYork Presbyterian Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

UPMC Heart & Vascular Institute

Harrisburg, Pennsylvania, United States

Key Dates

Start Date

December 8, 2020

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2029

Last Updated

January 12, 2024

Enrollment

ESTIMATED participants

Conditions

Mitral Valve Insufficiency

Interventions

Half Moon TMVr System

DEVICE

Contacts

Craig Straley

CONTACT

4153109197 craigstraley.halfmoon@gmail.com

Romil Rambhia

CONTACT

rrambhia@thefoundry.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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