Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
NCT ID: NCT00173186
Last Updated: 2005-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
411 participants
OBSERVATIONAL
1987-01-31
2005-02-28
Brief Summary
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Detailed Description
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From 1987 to 2002, 411 patients with complete follow-up after repair of outlet VSD constituted the study population. Study end point was aortic valve replacement or mortality.
Aortic valve replacement was performed in seventeen patients (4.1%), in whom logistic regression showed only the severity of preoperative AR and age at VSD repair as the predictors. After excluding the eleven patients with endocarditis from analysis, there were 377 patients with none to mild AR (Group I) and 23 with moderate to severe AR (Group II) preoperatively. Total follow-up was 2,230 person-years. After VSD repair, the 5- and 10-year freedom from aortic valve replacement in Group I was 100%, and in Group II 50.2%. In Group II, ten patients received aortic valve replacement and 8 underwent valvuloplasty with VSD repair. One patient needed valve replacement four years later. Age at VSD repair was the predictor for aortic valve replacement. In Group I, AR progressed in four patients (1.2%, two juxta-arterial and two perimembranous outlet) 3.5 to 7.9 years later and was associated with aortic valvar or subvalvar anomalies. The event-free curves in three outlet types VSD showed no differences.
Although AR progressed rarely (probably not in muscular outlet type) in repaired outlet types VSD with none to mild preoperative AR, in the presence of aortic valvar or subvalvar anomalies, early surgical repair of the VSD is still warranted.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* follow up more than 1 year after operation
Exclusion Criteria
0 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Principal Investigators
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Mei-Hwan Wu, MD, PhD
Role: STUDY_CHAIR
National Taiwan University Hospital
Locations
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Department of Pediatrics, National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Mei-Hwan Wu, MD, PhD
Role: primary
Shuenn-Nan Chiu, MD
Role: backup
Other Identifiers
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9461700517
Identifier Type: -
Identifier Source: org_study_id