Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects
Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
The purpose of this study is to investigate effectiveness and safety of transcatheter closure of perimembranous ventricular septal defects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2007
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFebruary 5, 2013
February 1, 2013
3.5 years
April 23, 2009
February 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Minor adverse events
Till study end
Study Arms (1)
occluders
EXPERIMENTALShanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.
Interventions
Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
Patient in this group received open surgical repair of pmVSD.
Eligibility Criteria
You may qualify if:
- Patients with ventricular septal defects eligible for transcatheter closure.
You may not qualify if:
- Patients less than 2 years old. Patients not suitable for transcatheter closure. Patients comorbid with other diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Related Publications (3)
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.
PMID: 26796197DERIVEDYang 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.
PMID: 24509270DERIVEDYang 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.
PMID: 20801925DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Yang, M.D., Ph. D.
Xijing Cardiovascular Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Jian Yang
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 30, 2009
Study Start
June 1, 2007
Primary Completion
December 1, 2010
Study Completion
July 1, 2012
Last Updated
February 5, 2013
Record last verified: 2013-02