Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation

NCT01703806 | Completed DMC

• 1 other identifier: 2007-0264
• Study Type: observational
• Target: 1,063
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mitral Regurgitation

Keywords

Mitral regurgitation; Mitral valve repair; Watchful waiting

Outcome Measures

Primary Outcomes (1)

• Cardiac mortality

  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.

  Up to 10 years

Secondary Outcomes (3)

• Repeat mitral valve surgery

  Up to 10 years

• Hospitalization due to congestive heart failure

  Up to 10 years

• A composite of cardiac events

  Up to 10 years

Study Arms (2)

Conventional Treatment

Patients in the conventional treatment group will be treated according to the 2006 ACC/AHA guidelines and they will be referred for surgery if they experience any symptoms, and referred for surgery if exertional dyspnea, LV ejection fraction \<0.60, LV end-systolic dimension \>40 mm, Doppler estimated pulmonary artery pressure \> 50 mmHg, or atrial fibrillation develops.

Procedure: Watchful Observation

Early Surgery

Patients in the early surgery group should undergo mitral valve surgery within 6 months of enrollment.

Procedure: Early Surgery

Interventions

Early Surgery PROCEDURE

MItral valve surgery

Early Surgery

Watchful Observation PROCEDURE

Watchful observation

Conventional Treatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From1996 to 2016, 1000 consecutive, asymptomatic patients with severe degenerative MR who are potential candidates for early surgery, will be enrolled in the present study. Severe degenerative MR is defined as severe prolapse and/or flail leaflet of the mitral valve with an effective regurgitant orifice area \> 0.40 square cm.

You may qualify if:

• asymptomatic patients
• severe degenerative MR
• preserved left ventricular systolic function

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (2)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (2)

• Kang DH, Kim JH, Rim JH, Kim MJ, Yun SC, Song JM, Song H, Choi KJ, Song JK, Lee JW. Comparison of early surgery versus conventional treatment in asymptomatic severe mitral regurgitation. Circulation. 2009 Feb 17;119(6):797-804. doi: 10.1161/CIRCULATIONAHA.108.802314. Epub 2009 Feb 2.

  PMID: 19188506 BACKGROUND

• Park SJ, Kim M, Son J, Jo HH, Kim GY, Kim J, Sun BJ, Kim EK, Lee S, Yoo JS, Yun SC, Jung SH, Song JM, Kang DH. Long-Term Outcomes of Early Surgery Versus Conventional Treatment for Asymptomatic Severe Mitral Regurgitation: A Propensity Analysis. Circulation. 2025 Oct 28;152(17):1209-1217. doi: 10.1161/CIRCULATIONAHA.125.074560. Epub 2025 Aug 13.

  PMID: 40799133 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Duk-Hyun Kang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: July 1, 1996
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

KR (2)