Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

Ventricular Septal Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890799
• Other study ID #: XJ-20090315
• Status: Completed
• Phase: N/A
• First received: April 23, 2009
• Last updated: February 2, 2013
• Start date: June 2007
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Ventricular Septal Defects

Intervention

Device:
• Shanghai pmVSD occluder
Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.

Procedure:
• surgery
Patient in this group received open surgical repair of pmVSD.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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