Working… Menu

Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890799
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
Jian Yang, Xijing Hospital

Brief Summary:
The purpose of this study is to investigate effectiveness and safety of transcatheter closure of perimembranous ventricular septal defects.

Condition or disease Intervention/treatment Phase
Ventricular Septal Defects Device: Shanghai pmVSD occluder Procedure: surgery Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects
Study Start Date : June 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: occluders
Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.
Device: Shanghai pmVSD occluder
Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
Other Name: Shanghai pmVSD-O

Procedure: surgery
Patient in this group received open surgical repair of pmVSD.
Other Name: open surgery

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890799

Sponsors and Collaborators
Xijing Hospital
Layout table for investigator information
Principal Investigator: Jian Yang, M.D., Ph. D. Xijing Cardiovascular Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jian Yang, Dr Jian Yang, Xijing Hospital Identifier: NCT00890799    
Other Study ID Numbers: XJ-20090315
First Posted: April 30, 2009    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Keywords provided by Jian Yang, Xijing Hospital:
transcatheter closure
ventricular septal defects
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities