Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
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|ClinicalTrials.gov Identifier: NCT00173186|
Recruitment Status : Unknown
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
|Condition or disease|
|Heart Septal Defects, Ventricular Aortic Valve Insufficiency|
Progression of aortic regurgitation (AR) in repaired outlet (juxta-arterial, muscular outlet and perimembranous outlet) ventricular septal defect (VSD) remains unclear.
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.
|Study Type :||Observational|
|Estimated Enrollment :||411 participants|
|Observational Model:||Case Control|
|Observational Model:||Natural History|
|Official Title:||Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect|
|Study Start Date :||January 1987|
|Estimated Study Completion Date :||February 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173186
|Contact: Mei-Hwan Wu, MD, PhD||886-2-23123456 ext email@example.com|
|Contact: Shuenn-Nan Chiu, MD||886-2-23123456 ext firstname.lastname@example.org|
|Department of Pediatrics, National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Mei-Hwan Wu, MD, PhD 886-2-23123456 ext 5126 email@example.com|
|Contact: Shuenn-Nan Chiu, MD 886-2-23123456 ext 5126 firstname.lastname@example.org|
|Study Chair:||Mei-Hwan Wu, MD, PhD||National Taiwan University Hospital|