Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

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

Detailed Description
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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.

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

Conditions
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Ventricular Septal Defects

Intervention / Treatment
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* Device: Shanghai pmVSD occluder
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: occluders<br>Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study. | Device: Shanghai pmVSD occluder<br>* Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.<br>* Other names: Shanghai pmVSD-O;Procedure: surgery<br>* Patient in this group received open surgical repair of pmVSD.<br>* Other names: open surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events | 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. | till study end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor adverse events | 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. | Till study end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcatheter closure, ventricular septal defects