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NCT03929913 · ClinicalTrials.gov registry record · NA
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
A NA study of Functional Mitral Regurgitation, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Active
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 3
- Study locations
NCT03929913: Active NA study of Functional Mitral Regurgitation, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03929913 is a NA study of Functional Mitral Regurgitation that is active but no longer recruiting, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 19 participants, below the 427-participant average among 5 other Functional Mitral Regurgitation trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03929913, a NA study of Functional Mitral Regurgitation, is active but no longer recruiting, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
The primary endpoint is Technical success. This endpoint is measured at exit from the catheterization laboratory. All of the following must be present: 1. Alive 2. Successful deployment and correct positioning of a single intended Transcatheter Mitral Cerclage Annuloplasty (TMCA). Repositioning and recapture of the device, if needed, is not classified as failure. 3. Retrieval of the TMCA delivery system 4. Absence of TMCA-related coronary artery compression and absence of additional procedure s
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 |
What the registry record for NCT03929913 still lists
NCT03929913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 427-participant average among 5 other Functional Mitral Regurgitation trials with a reported enrollment target (96% lower).
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.
NCT03929913 reports a single indexed study location in District of Columbia, Georgia, Virginia.
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.
What interventions are being tested in trial NCT03929913?
The interventions under investigation include: Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) (DEVICE).
Who is sponsoring clinical trial NCT03929913?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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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