Degenerative Mitral Regurgitation in Intermediate Risk Patients
Completed
Conditions studied: Mitral Valve Insufficiency, Mitral Regurgitation
In brief
The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for degenerative mitral regurgitation.
Key facts
- Study ID
- NCT02604745
- Run by
- Northwestern University
- People needed
- 13
- Starts
- 2016-03-01
- Expected to finish
- 2021-01-01
- Last updated by the study team
- 2021-04-01
Who can join
Age: 65 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prior surgery for degenerative mitral regurgitation (DMR) at Northwestern Memorial Hospital performed by a single surgeon.
- Male and female ≥ 65 years of age at time of index procedure.
- Mitral Valve surgery performed > 6 months and <36 months at the time of consent. Concomitant procedures at time of index procedure may include incidental CAB, MAZE and tricuspid valve surgery.
- STS (Society of Thoracic Surgeons) mortality risk score of ≥ 2 and < 6 for mitral valve repair or ≥ 2 and < 8 for mitral valve replacement at time of index procedure.
- Able to speak, read, and understand English
You may not qualify if…
- Pre-operative tricuspid regurgitation of 4+ (severe) at time of index procedure.
- Severe RV Dysfunction.
- Contraindication to exercise testing (i.e., Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, etc.).
- Unable to perform an exercise test due to clinical criteria such oxygen dependency, neuromuscular limitations, NYHA class 4, unstable angina, and postural hypotension.
- Surgical or interventional cardiac procedure or other intervention since the index procedure that in the opinion of the Investigator may confound data analysis.
- Left ventricular ejection fraction <30%.
- Subjects unwilling or unable to give written informed consent.
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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