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NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
NCT03929913 · View on ClinicalTrials.gov ↗
Study Summary
This research protocol tests a new technique and devices that we have developed to treat functional mitral valve regurgitation, called transcatheter mitral valve cerclage annuloplasty, otherwise known as "cerclage". Functional mitral valve regurgitation is a condition caused by damaged heart muscle involving the left ventricle which results in mitral valve leakage. This leakage causes heart failure (breathlessness and lack of energy especially when walking or exercising, and hospital admissions for fluid buildup). This is an early feasibility study (EFS) evaluation of special devices, permanently implanted in the heart, to perform mitral cerclage annuloplasty. Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery. The cerclage devices compress the mitral valve like a purse-string. The cerclage device has a special feature that prevents a coronary artery from getting squeezed as part of this purse-string. The protocol has been changed to allow patients who have mitral valve regurgitation despite prior Mitra-Clip treatment, and to allow patients who have symptomatic heart failure with mild mitral regurgitation.
Conditions Studied
Interventions
- DEVICE Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)
Study Locations (3)
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Georgia
- Emory University — Atlanta
Virginia
- Carilion Medical Center — Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-05-07 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03929913
The ClinicalTrials.gov registry entry for NCT03929913 describes a study currently listed as active not 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 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 381 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 Functional Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention — of which Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) 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: NCT03929913 reports 3 study locations spanning 3 distinct geographic areas — top geographies include District of Columbia, Georgia, Virginia. 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 NCT03929913 about?
NCT03929913 is a clinical study titled "NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study". This research protocol tests a new technique and devices that we have developed to treat functional mitral valve regurgitation, called transcatheter mitral valve cerclage annuloplasty, otherwise known as "cerclage". Functional mitral valve regurgitation is a condition caused by damaged heart muscle ...
What is the current status of trial NCT03929913?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 19 participants. The study started on 2019-05-07. Estimated completion is 2025-12-31.
What conditions does trial NCT03929913 study?
This clinical trial studies the following conditions: Functional Mitral Regurgitation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03929913?
The interventions under investigation include: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03929913?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 381 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03929913 being conducted?
This trial has 3 study locations across District of Columbia, Georgia, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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