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The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
NCT04343313 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04343313
The ClinicalTrials.gov registry entry for NCT04343313 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Half Moon Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04343313 reports 5 study locations spanning 4 distinct geographic areas — top geographies include New York, Ohio, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04343313?
The interventions under investigation include: Half Moon TMVr System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04343313?
This trial is sponsored by Half Moon Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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