NCT00173186

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1987

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1987

Completed
18.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

June 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Heart Septal Defects, VentricularAortic Valve Insufficiency

Keywords

ventricular septal defectaortic regurgitation

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ventricular septal defect patients receiving total repair from Jan, 1987 to Dec, 2002.
  • follow up more than 1 year after operation

You may not qualify if:

  • complex cardiac lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, VentricularAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Mei-Hwan Wu, MD, PhD

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Mei-Hwan Wu, MD, PhD

CONTACT

886-2-23123456mhwu@ha.mc.ntu.edu.tw

Shuenn-Nan Chiu, MD

CONTACT

886-2-23123456michael@ha.mc.ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 1987

Study Completion

February 1, 2005

Last Updated

September 15, 2005

Record last verified: 2005-06

Locations

TW(1)