Improving Mitral Repair for Functional Mitral Regurgitation

Stopped early · Not applicable

Conditions studied: Cardiomyopathy, Cardiovascular Diseases, Congestive Heart Failure, Coronary Artery Disease, Heart Disease, Valvular Heart Disease, Mitral Valve Disease

In brief

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.

Key facts

Study ID: NCT03366649
Run by: Emory University
People needed: 34
Starts: 2018-03-20
Expected to finish: 2023-12-31
Last updated by the study team: 2025-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Mitral regurgitation of moderate or greater severity, as defined by the guidelines of the American Society of Echocardiography (via a transthoracic echo)
Cardiomyopathy of ischemic or non-ischemic origins, with or without the need for coronary revascularization
Concomitant right-sided valve repair or replacement (i.e. patients requiring concomitant tricuspid procedures)
Able to sign informed consent and release of medical information forms

You may not qualify if…

Any evidence of structural (chordal or leaflet) mitral lesions
Prior mitral valve repair
Contraindication for cardiopulmonary bypass
Clinical signs of cardiogenic shock at the time of randomization
ST-segment elevation myocardial infarction within 14 days before inclusion in this study
Congenital heart disease, except patent foramen ovale (PFO) or atrial septal defect (ASD)
Chronic renal insufficiency defined by creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery
Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator
Pregnancy at the time of randomization

Where it is running

Emory University Hospital Midtown — Atlanta, Georgia, United States
Emory University Hospital — Atlanta, Georgia, United States
Emory St. Joseph's Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.