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

Not Applicable

Completed

• 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; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000308796
• Lead Sponsor: A/Professor Christian Brizard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-20
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To confirm the safety profile of CardioCel when used to repair the defect(s) associated with Congenital Heart Disease being studied. Adverse event profile will be assessed intraoperatively, perioperatively and at 30 days. All adverse events will be recorded throughout the duration of the study. A cardio echo will be performed at a number of follow up visits (30 days and 12 months post op) to assess the haemodynamic performance of the area around the graft and to detect any clinical abnormalities. [Intra-operatively, peri-operatively, 30 days and 12 months]

Secondary Outcome Measures

Name	Time	Method
To evaluate echocardiographic aspect at 30 days and 12 months compared to baseline. <br>[The echocardiograph will be performed at 30 days post op and 12 months post op. ];The evaluation of incidence of short and long term calcification of the grated patch and assessment of patch integrity will be by echocardiograph. <br>[Evidence of calcification and patch integrity will be confirmed by echocardiograph at 12 months post op. ]