Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

NCT ID: NCT00890799

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-07-31

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.

Conditions

Ventricular Septal Defects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

occluders

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

Group Type: EXPERIMENTAL

Shanghai pmVSD occluder

Intervention Type: DEVICE

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

surgery

Intervention Type: PROCEDURE

Patient in this group received open surgical repair of pmVSD.

Interventions

Shanghai pmVSD occluder

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

Intervention Type: DEVICE

surgery

Patient in this group received open surgical repair of pmVSD.

Intervention Type: PROCEDURE

Other Intervention Names

Shanghai pmVSD-O; open surgery

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Yang

Dr Jian Yang

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Xijing Cardiovascular Hospital

References

Wang J, Zuo J, Yu S, Yi D, Yang X, Zhu X, Li J, Yang L, Xiong L, Ge S, Ren J, Yang J. Effectiveness and Safety of Transcatheter Closure of Perimembranous Ventricular Septal Defects in Adults. Am J Cardiol. 2016 Mar 15;117(6):980-7. doi: 10.1016/j.amjcard.2015.12.036. Epub 2015 Dec 31.

Reference Type: DERIVED

PMID: 26796197 (View on PubMed)

Yang J, Yang L, Yu S, Liu J, Zuo J, Chen W, Duan W, Zheng Q, Xu X, Li J, Zhang J, Xu J, Sun L, Yang X, Xiong L, Yi D, Wang L, Liu Q, Ge S, Ren J. Transcatheter versus surgical closure of perimembranous ventricular septal defects in children: a randomized controlled trial. J Am Coll Cardiol. 2014 Apr 1;63(12):1159-1168. doi: 10.1016/j.jacc.2014.01.008. Epub 2014 Feb 5.

Reference Type: DERIVED

PMID: 24509270 (View on PubMed)

Yang J, Yang L, Wan Y, Zuo J, Zhang J, Chen W, Li J, Sun L, Yu S, Liu J, Chen T, Duan W, Xiong L, Yi D. Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes. Eur Heart J. 2010 Sep;31(18):2238-45. doi: 10.1093/eurheartj/ehq240. Epub 2010 Aug 27.

Reference Type: DERIVED

PMID: 20801925 (View on PubMed)

Other Identifiers

XJ-20090315

Identifier Type: -

Identifier Source: org_study_id