Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation
About the study
The timing of surgical intervention in asymptomatic patients with severe degenerative mitral regurgitation (MR) remains controversial. The benefit of early surgery has been suggested in prospective, observational studies, whereas a watchful waiting strategy seemed to be safe and effective in the other prospective study. The consensus guidelines for the performance of early surgery in asymptomatic patients with severe MR are different, reflecting controversy. Clinical outcome in asymptomatic patients with MR is poorly defined and it is important to identify high-risk patients in whom early surgery may be warranted. Thus, the investigators try to compare long-term outcomes of early surgery with those of a conventional-treatment strategy in a large prospective cohort of asymptomatic patients with severe degenerative MR using a propensity analysis, and to identify high-risk subgroups to whom early surgery is more beneficial.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- asymptomatic patients
- severe degenerative MR
- preserved left ventricular systolic function
EXCLUSION CRITERIA
Exclusion Criteria: According to the recommendations of the 2006 American College of Cardiology/American Heart Association (ACC/AHA) guidelines for surgical indications of severe MR, the criteria for exclusion from the study are defined as follows.
- patients with the presence of exertional dyspnea, or angina
- left ventricular ejection fraction < 0.60
- left ventricular end-systolic dimension > 40 mm
- atrial fibrillation
- significant aortic valve disease
- Doppler-estimated systolic pulmonary artery pressure > 50 mmHg
- patients who were not candidates for early surgery based on age > 80 years and coexisting malignancies
- patients who did not consent to participate
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Mitral Regurgitation
Age (in years)
20 - 80
Participants needed
600
Est. Completion Date
Aug 31, 2023
Treatment type
Observational
Sponsor
Asan Medical Center
ClinicalTrials.gov identifier
NCT01703806
Study number
20070264
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