Status:
TERMINATED
Improving Mitral Repair for Functional Mitral Regurgitation
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiomyopathy
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Functional mitral regurgitation (FMR) is a common heart valve lesion that is observed in patients suffering for cardiomyopathies. Timely surgical repair of FMR can reduce volume overload and potential...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03366649
Start Date
March 20 2018
End Date
December 31 2023
Last Update
January 16 2025
Active Locations (3)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Emory St. Joseph's Hospital
Atlanta, Georgia, United States, 30342