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

Part of paid clinical trials in New York, New York.

Sponsor
Half Moon Medical
Study ID
NCT04343313
Status
Recruiting
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Conditions

  • Mitral Valve Insufficiency

Eligibility Criteria

Sex
ALL
Age
21 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Half Moon TMVr System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 8, 2020
Status verified
Jan 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • 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.

Primary Outcome Measure

Adverse Events [ Time Frame: 30 Days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Columbia University Medical Center/NewYork Presbyterian HospitalNew YorkNew York10032
Susheel Kodali, MD
[email protected]
Kate Dalton
[email protected]
Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Azeem Latib, MD
University Hospitals Cleveland Medical CenterClevelandOhio44106
Guilherme Attizzani, MD
Oregon Health & Science UniversityPortlandOregon97239
Firas Zahr, MD
UPMC Heart & Vascular InstituteHarrisburgPennsylvania17104
Hemal Gada, MD

Find similar trials in New York, NY

By research site
Columbia University Medical Center/NewYork Presbyterian Hospital· New York, NYMontefiore Medical Center· The Bronx, NYUniversity Hospitals Cleveland Medical Center· Cleveland, OHOregon Health & Science University· Portland, ORUPMC Heart & Vascular Institute· Harrisburg, PA

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