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Clinical Trials/ACTRN12613000308796
ACTRN12613000308796
Completed
未知

A Pilot Study to evaluate Safety and Efficacy of the Adapt Pericardial Patch in the repair of defects associated with Congenital Heart Disease in participants aged between 1 and 12 years of age.

A/Professor Christian Brizard0 sites40 target enrollmentMarch 20, 2013
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ConditionsCongenital Heart Disease including ventricular septal defect repair, atrial ventricular septal defect, atrio ventricular septal defects as determined by clinical assessment including MRI and echo cardiographyCardiovascular - Other cardiovascular diseases

Overview

Phase
未知
Intervention
Not specified
Conditions
Congenital Heart Disease including ventricular septal defect repair, atrial ventricular septal defect, atrio ventricular septal defects as determined by clinical assessment including MRI and echo cardiography
Sponsor
A/Professor Christian Brizard
Enrollment
40
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 20, 2013
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
A/Professor Christian Brizard

Eligibility Criteria

Inclusion Criteria

  • •1\. Between the ages of 1 day and 12 years at the time or enrolment.
  • •2\. Has a congenital heart disease (including ventricular septal defect repair (VSD), atrial ventricular septal defect repair (VSD), atrio ventricular septal defects (AVSD) as determined by clinical assessment including echo cardiography and/or MRI
  • •3\. Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the subject's behalf.
  • •4\. Willing and able to complete all study visits and procedures

Exclusion Criteria

  • •1\. Has a clinically confirmed infection
  • •2\. Has co\-morbidities which are likely to lead to death within the study follow up period.
  • •3\. Is participating in another study.
  • •4\. Is likely to require additional surgical intervention using a bioprosthetic material.
  • •5\. Unwilling or unable to comply with treatment follow up requirements.
  • •6\. Any other clinical condition which leads the investigator to consider the subject unsuitable for enrolment into the study.

Outcomes

Primary Outcomes

Not specified

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