NCT00890799

Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate effectiveness and safety of transcatheter closure of perimembranous ventricular septal defects.

Detailed description

Perimembranous Ventricular septal defect (VSD) is the most common congenital cardiac malformation and constitutes over 20% of all congenital cardiac disease. Though conventional surgery for VSD is a widely accepted procedure with minimal operative mortality, it carries a small but definite risk of morbidity and mortality associated with cardiopulmonary bypass and surgical closure. The newly appeared transcatheter device closure technique provides an alternative to surgical closure. However, the mid-to-long term effects of this technique using occluders is not clear. The aim of this study was to evaluate the safety and effectiveness of transcatheter closure of perimembranous ventricular septal defects using septal occluders.

Conditions

• Ventricular Septal Defects

Interventions

Type	Name	Description
DEVICE	Shanghai pmVSD occluder	Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
PROCEDURE	surgery	Patient in this group received open surgical repair of pmVSD.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-12-01
• Completion: 2012-07-01
• First posted: 2009-04-30
• Last updated: 2013-02-05