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

September 12, 2005 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment

411

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Department of Pediatrics, National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Mei-Hwan Wu, MD, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1987

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9461700517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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