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

NCT04343313 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-12

No results posted yet for this study

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.

Conditions

  • Mitral Valve Insufficiency

Interventions

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.

Sponsors & Collaborators

  • Half Moon Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2024-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04343313 on ClinicalTrials.gov