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Completed

NCT Number: NCT00890799

Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

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

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Key information

Conditions

Ventricular Septal Defects Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shanghai pmVSD occluder

Device

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

Other names: Shanghai pmVSD-O

Surgery

Procedure

Patient in this group received open surgical repair of pmVSD.

Other names: open surgery

Primary outcomes

  1. 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

  1. Minor adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Apr 30, 2009
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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