Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

Xijing Hospital200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Ventricular Septal Defects

Interventions

Shanghai pmVSD occluderDEVICE

Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.

surgeryPROCEDURE

Patient in this group received open surgical repair of pmVSD.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: till study end

Secondary Outcomes

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.

Time frame: Till study end

Data from ClinicalTrials.gov

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