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NCT03366649 · ClinicalTrials.gov registry record · NA
Improving Mitral Repair for Functional Mitral Regurgitation
A NA study, sponsored by Emory University.
- Terminated
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT03366649: Clinical Trial NA study, sponsored by Emory University.
NCT03366649 is a NA study that was terminated before completion, run by Emory University. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03366649, a NA study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other. The technique used in current clinical practice is undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Though widely adopted, durability of the repair is less, as 58% of the patients present with recurrent FMR within 2 years. There are no specific algorithms to predict who might have UMA failure, but research indicates that some geometric indices might be strong predictors. The investigators are interested in testing the hypothesis that, elevated lateral inter-papillary muscle separation (IPMS) is a predictor of post-UMA recurrence of FMR at 12 months. In the first part of this study, the study team will measure lateral IPMS before surgery and relate to post-surgery FMR severity at discharge/30 days, 6 months and 12 months. A relatively newer technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. This reduces the lateral inter-papillary muscle separation (IPMS) and is expected to improve the durability of UMA. In the second part of this study, the investigators will perform PMA and UMA together and determine if FMR severity is reduced at discharge/30 days, 6 months and 12 months.
Primary Outcome
The Severity (grade 0 to 4+) of mitral regurgitation of mitral regurgitation is measured using cardiac echocardiography and/or MRI (per physician's discretion). Grade 0: None Grade 1 (Mild): Small, restricted jet of regurgitation with minimal impact on the heart's function. Typically, no symptoms and normal or near-normal left ventricular function. Grade 2 (Moderate): Moderate jet size with some effect on the heart, but symptoms may still be absent or minimal. Mild to moderate left ventricular
Interventions
- PROCEDURE Undersizing Mitral Annuloplasty
- PROCEDURE Papillary Muscle Approximation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-03-20 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
Why NCT03366649 stopped before completion
NCT03366649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Undersizing Mitral Annuloplasty is the first listed.
NCT03366649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03366649 about?
NCT03366649 is a clinical study titled "Improving Mitral Repair for Functional Mitral Regurgitation". The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other. The technique used in current clinical practice is undersizing mitral annuloplasty (UMA)...
What is the current status of trial NCT03366649?
This trial is currently terminated. It is a NA study. The enrollment target is 34 participants. The study started on 2018-03-20. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT03366649?
The interventions under investigation include: Undersizing Mitral Annuloplasty (PROCEDURE), Papillary Muscle Approximation (PROCEDURE).
Who is sponsoring clinical trial NCT03366649?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03366649's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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