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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.
 
ClinicalTrials.gov Identifier: NCT00890799
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Jian Yang, Xijing Hospital

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 30, 2009
Last Update Posted Date February 5, 2013
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2009)
Late loss [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT00890799 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects
Official Title  ICMJE Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Septal Defects
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: occluders
Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.
Interventions:
  • Device: Shanghai pmVSD occluder
  • Procedure: surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2013)
200
Original Actual Enrollment  ICMJE
 (submitted: April 29, 2009)
2
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00890799
Other Study ID Numbers  ICMJE XJ-20090315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian Yang, Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jian Yang, M.D., Ph. D. Xijing Cardiovascular Hospital
PRS Account Xijing Hospital
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP