Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jian Yang, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00890799
First received: April 23, 2009
Last updated: February 2, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Ventricular Septal Defects
Device: Shanghai pmVSD occluder
Procedure: surgery

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Major adverse events [ Time Frame: till study end ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Till study end ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 200
Study Start Date: June 2007
Study Completion Date: July 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00890799

Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Jian Yang, M.D., Ph. D. Xijing Cardiovascular Hospital
  More Information

No publications provided by Xijing Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jian Yang, Dr Jian Yang, Xijing Hospital
ClinicalTrials.gov Identifier: NCT00890799     History of Changes
Other Study ID Numbers: XJ-20090315
Study First Received: April 23, 2009
Last Updated: February 2, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
transcatheter closure
ventricular septal defects

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 31, 2014