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NCT04343313 · ClinicalTrials.gov registry record · NA
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
A NA study of Mitral Valve Insufficiency, sponsored by Half Moon Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT04343313: Recruiting NA study of Mitral Valve Insufficiency, sponsored by Half Moon Medical.
NCT04343313 is a NA study of Mitral Valve Insufficiency that is actively recruiting participants, run by Half Moon Medical. The registered enrollment target is 30 participants, below the 383-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04343313, a NA study of Mitral Valve Insufficiency, is actively recruiting participants, sponsored by Half Moon Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Evaluation of the nature, severity and frequency of complications associated with the delivery and/or implantation of the device
Conditions Studied
Interventions
- DEVICE Half Moon TMVr System
Study Locations (5)
New York
- Columbia University Medical Center/NewYork Presbyterian Hospital - New York
- Montefiore Medical Center - The Bronx
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- UPMC Heart & Vascular Institute - Harrisburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2029-12-31 |
| Phase | NA |
What NCT04343313 shows while recruiting
NCT04343313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 383-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Mitral Valve Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Half Moon TMVr System is the first listed.
NCT04343313 lists 5 locations in 4 states (New York, Ohio, Oregon).
Frequently Asked Questions
What is clinical trial NCT04343313 about?
NCT04343313 is a clinical study titled "The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study". 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.
What is the current status of trial NCT04343313?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2020-12-08. Estimated completion is 2029-12-31.
What conditions does trial NCT04343313 study?
This clinical trial studies the following conditions: Mitral Valve Insufficiency.
What interventions are being tested in trial NCT04343313?
The interventions under investigation include: Half Moon TMVr System (DEVICE).
Who is sponsoring clinical trial NCT04343313?
This trial is sponsored by Half Moon Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04343313 being conducted?
This trial has 5 study locations across New York, Ohio, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mitral Valve Insufficiency
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Where NCT04343313's enrollment target sits among peer trials
30 12th of 11 the lowest of 11 other Mitral Valve Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Valve Insufficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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-
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