Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

This study is testing a new device called the Half Moon Transcatheter Mitral Valve Repair (TMVr) System. This system is designed to fix a leaky mitral valve (mitral regurgitation) in your heart without open-heart surgery. It's for people aged 21 to 95 who have severe symptoms from their leaky valve and are considered too high-risk for traditional surgery. The main goal of this study is to see how safe the Half Moon TMVr System is. The study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an Early Feasibility Study (EFS) that will enroll 30 participants. It is a single-arm study, meaning all participants will receive the Half Moon TMVr System.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for at least 30 days after the procedure.

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NCT04343313

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

Recruiting
NAAges 21–95InterventionalDevice feasibility
Half Moon Medical
~30 participants
Updated 2024-01-12 on ClinicalTrials.gov
What's tested:Half Moon TMVr System

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over 30 Days
Mitral Valve Insufficiency
5 sites across 4 states
New York2
Ohio1
Oregon1
Pennsylvania1

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  • Adverse Events30 Days

    Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device