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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173186
First received: September 12, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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.


Condition
Heart Septal Defects, Ventricular
Aortic Valve Insufficiency

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Longitudinal
Official Title: Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 411
Study Start Date: January 1987
Estimated Study Completion Date: February 2005
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00173186

Contacts
Contact: Mei-Hwan Wu, MD, PhD 886-2-23123456 ext 5126 mhwu@ha.mc.ntu.edu.tw
Contact: Shuenn-Nan Chiu, MD 886-2-23123456 ext 5126 michael@ha.mc.ntu.edu.tw

Locations
Taiwan
Department of Pediatrics, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Mei-Hwan Wu, MD, PhD    886-2-23123456 ext 5126    mhwu@ha.mc.ntu.edu.tw   
Contact: Shuenn-Nan Chiu, MD    886-2-23123456 ext 5126    michael@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Mei-Hwan Wu, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00173186     History of Changes
Other Study ID Numbers: 9461700517
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
ventricular septal defect
aortic regurgitation

Additional relevant MeSH terms:
Heart Septal Defects
Aortic Valve Insufficiency
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Valve Diseases

ClinicalTrials.gov processed this record on September 29, 2014