Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Ventricular Septal Defects

Treatments: Device: Shanghai pmVSD occluder; Procedure: surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00890799

XJ-20090315

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 2 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ventricular septal defects eligible for transcatheter closure.

Exclusion criteria

• Patients less than 2 years old. Patients not suitable for transcatheter closure. Patients comorbid with other diseases.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 1 patient group

occluders

Experimental group

Description:

Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.

Treatment:

Procedure: surgery

Device: Shanghai pmVSD occluder