Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventricular Septal Defects
- Sponsor
- Xijing Hospital
- Enrollment
- 200
- Primary Endpoint
- Major adverse events
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Jian Yang
Dr Jian Yang
Xijing Hospital
Eligibility Criteria
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
Time Frame: 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 Outcomes
- Minor adverse events(Till study end)