Transcatheter Closure Versus Surgery of Perimembranous Ventricular Septal Defects

February 2, 2013 updated by: Jian Yang, Xijing Hospital

Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects

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

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: occluders
Shanghai pmVSD occluder (LEPU Medical Tech-nology Co, Ltd, Beijing, China) was used in this study.
Ventricular Septal Defects Occluders with sizes from 4mm to 20mm.
Other Names:
  • Shanghai pmVSD-O
Patient in this group received open surgical repair of pmVSD.
Other Names:
  • open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
till study end

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Till study end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jian Yang, M.D., Ph. D., Xijing Cardiovascular Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 29, 2009

First Posted (ESTIMATE)

April 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 2, 2013

Last Verified

February 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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