Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Early Surgery Versus Conventional Treatment for Asymptomatic Patients With Severe Degenerative Mitral Regurgitation: A Propensity Analysis|
- Cardiac mortality [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Cardiac mortality is defined as operative mortality, sudden cardiac death, death from complications of myocardial infarction, heart failure, complications of cardiac intervention or other cardiac disease. Operative mortality is defined as death within 30 days of mitral valve surgery.
- Repeat mitral valve surgery [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Hospitalization due to congestive heart failure [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]A congestive heart failure hospitalization is defined as an unplanned, urgent admission for the management of congestive heart failure . A patient admitted for congestive heart failure have to show resting dyspnea and radiological signs of pulmonary edema and require intravenous diuretics.
- A composite of cardiac events [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]A composite of cardiac mortality, repeat MV surgery and hospitalization due to congestive heart failure during follow-up.
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Asymptomatic patients with severe degenerative mitral regurgitation
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01703806
|Contact: Duk-Hyun Kang, MD, PhDfirstname.lastname@example.org|
|Contact: Dae-Hee Kim, MD, PhDemail@example.com|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Duk-Hyun Kang, MD, PhD 82-2-3010-3166 firstname.lastname@example.org|
|Principal Investigator: Duk-Hyun Kang, MD, PhD|
|Principal Investigator:||Duk-Hyun Kang, MD, PhD||Asan Medical Center|