Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects
Primary Purpose
Ventricular Septal Defects
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shanghai pmVSD occluder
surgery
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Septal Defects focused on measuring transcatheter closure, ventricular septal defects
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
occluders
Arm Description
Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Minor adverse events
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00890799
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Septal Defects
Keywords
transcatheter closure, ventricular septal defects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
occluders
Arm Type
Experimental
Arm Description
Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.
Intervention Type
Device
Intervention Name(s)
Shanghai pmVSD occluder
Other Intervention Name(s)
Shanghai pmVSD-O
Intervention Description
Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
Intervention Type
Procedure
Intervention Name(s)
surgery
Other Intervention Name(s)
open surgery
Intervention Description
Patient in this group received open surgical repair of pmVSD.
Primary Outcome Measure Information:
Title
Major adverse events
Description
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.
Time Frame
till study end
Secondary Outcome Measure Information:
Title
Minor adverse events
Description
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.
Time Frame
Till study end
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Yang, M.D., Ph. D.
Organizational Affiliation
Xijing Cardiovascular Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26796197
Citation
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.
Results Reference
derived
PubMed Identifier
24509270
Citation
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.
Results Reference
derived
PubMed Identifier
20801925
Citation
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.
Results Reference
derived
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Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects
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