Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that was terminated before completion, run by Emory University. The registered enrollment target is 34 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03366649
The ClinicalTrials.gov registry entry for NCT03366649 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Undersizing Mitral Annuloplasty is the first listed.
NCT03366649 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.