Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect

Aortic Valve Insufficiency Clinical Trial

Official title:

Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00173186
• Other study ID #: 9461700517
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: January 1987
• Est. completion date: February 2005

Study information

• Verified date: June 2005
• Source: National Taiwan University Hospital
• Contact: Mei-Hwan Wu, MD, PhD
• Phone: 886-2-23123456
• Email: mhwu[@]ha.mc.ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

The major risk factors of aortic valve replacement in three outlet types VSD after surgical repair were the severity of preoperative AR and older operation age. For those patients with less than moderate degree AR preoperatively, AR progressed rarely and all in those with aortic valvar and subvalvar anomalies.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 411
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ventricular septal defect patients receiving total repair from Jan, 1987 to Dec, 2002.

• follow up more than 1 year after operation

Exclusion Criteria:

• complex cardiac lesions

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Heart Septal Defects
• Heart Septal Defects, Ventricular

Locations

Country	Name	City	State
Taiwan	Department of Pediatrics, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,