Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

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Brief Title

Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

Official Title

Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous 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.
    


Study Type

Interventional


Primary Outcome

Major adverse events

Secondary Outcome

 Minor adverse events

Condition

Ventricular Septal Defects

Intervention

Shanghai pmVSD occluder

Study Arms / Comparison Groups

 occluders
Description:  Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

200

Start Date

June 2007

Completion Date

July 2012

Primary Completion Date

December 2010

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.
      

Gender

All

Ages

2 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jian Yang, M.D., Ph. D., , 



Administrative Informations


NCT ID

NCT00890799

Organization ID

XJ-20090315


Responsible Party

Principal Investigator

Study Sponsor

Xijing Hospital


Study Sponsor

Jian Yang, M.D., Ph. D., Principal Investigator, Xijing Cardiovascular Hospital


Verification Date

February 2013