- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00890799
Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects
February 2, 2013 updated by: Jian Yang, Xijing Hospital
Clinical Evaluation of Transcatheter Closure and 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 80 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: occluders
Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.
|
Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
Other Names:
Patient in this group received open surgical repair of pmVSD.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
till study end
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Till study end
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jian Yang, M.D., Ph. D., Xijing Cardiovascular Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
April 23, 2009
First Submitted That Met QC Criteria
April 29, 2009
First Posted (ESTIMATE)
April 30, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 5, 2013
Last Update Submitted That Met QC Criteria
February 2, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJ-20090315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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