Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

Not Applicable

Completed

• Conditions: Ventricular Septal Defects
• Interventions: Device: Shanghai pmVSD occluder; Procedure: surgery

• Registration Number: NCT00890799
• Lead Sponsor: Xijing Hospital

Brief 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-29
• Study First Posted: 2009-04-30
• Primary Completion: 2010-12
• Study Completion: 2012-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-02
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Major adverse events	till study end	Major adverse events included but were not limited to death during or after the procedure because of complications of the procedure,cAVB requiring pacemaker implantation, thromboembolism, and new-onset valvular regurgitation requiring surgical repair.

Secondary Outcome Measures

Name	Time	Method
Minor adverse events	Till study end	Minor adverse events included but were not limited to groin hematoma, blood loss requiring transfusion, device embolization with transcatheter removal, any cardiac arrhythmia that required medication, new or increased valvular regurgitation less than two grades, hemolysis requiring medication, fever \>38.5°C, rash, and loss of peripheral pulse. These minor adverse events required medical intervention but were not life threatening; they had no long-term sequelae and did not require long-term therapy.