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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
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Septal Defects focused on measuring transcatheter closure, ventricular septal defects

Eligibility Criteria

2 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 23, 2009
    Last Updated
    February 2, 2013
    Sponsor
    Xijing Hospital
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    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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