Status:
UNKNOWN
The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise Capacity
Lead Sponsor:
Atlantic Health System
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Brief Summary
Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains...
Detailed Description
Current ACC/AHA guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regardin...
Eligibility Criteria
Inclusion
- Age \>=18 yrs
- able to give informed consent
- Diagnoses of moderate or severe degenerative mitral regurgitation (based on the integrated approach recommended by the American Society of Echocardiography)
Exclusion
- Left ventricular ejection fraction \<60%
- Heart failure
- Pulmonary hypertension (pulmonary artery systolic pressure \>40mmHg at rest or \>60mmHg with exercise as assessed by echocardiography)
- Atrial fibrillation
- Concomitant \> mild aortic or mitral stenosis, \>mild aortic or tricuspid or pulmonic regurgitation
- Prior valvular heart disease surgery
- Hypertrophic cardiomyopathy or an infiltrative cardiomyopathy
- Unable to exercise on a treadmill
- Symptomatic coronary artery disease
- Comorbidities expected to impact functional capacity and confound symptom assessment (e.g COPD)
- Expected lifespan of less than 2 years
Key Trial Info
Start Date :
August 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04051411
Start Date
August 7 2019
End Date
January 1 2024
Last Update
August 21 2019
Active Locations (1)
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1
Morristown Medical Center
Morristown, New Jersey, United States, 07960