Ventricular Septal Defects
Conditions
Keywords
transcatheter closure, ventricular septal defects
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.
Interventions
PROCEDUREsurgery
Patient in this group received open surgical repair of pmVSD.
DEVICEShanghai pmVSD occluder
Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed