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Trial registered on ANZCTR


Registration number
ACTRN12613000308796
Ethics application status
Approved
Date submitted
19/03/2013
Date registered
20/03/2013
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Date results information initially provided
7/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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.
Secondary ID [1] 282143 0
Nil
Universal Trial Number (UTN)
U1111-1140-7186
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 288647 0
Condition category
Condition code
Cardiovascular 288986 288986 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Adapt Pericardial Patch (CardioCel) (4 x 4 cm) will be used for the repair of defects associated with Congenital Heart Disease. The research question is to assess whether the patch's integrity is maintained during follow-up (performation or aneurismal formation). CardioCel is comprised of tissue engineered bovine pericardium that is cross linked in diluted glutaraldehyde solution and treated with the ADAPT TEP technology. Only one size of CardioCel is available (4x4cm). CardioCel may be sutured or stapled in place. CardioCel is stored at room temperature, never below 5 degrees celcius or above 25 degrees celcius and away from direct heat source. The implant should not be re-sterilised. No extensive rinsing is required. The patch is immersed in sterile physiological saline to avoid dehydration of the patch prior to implantation. Implantation specifics will be determined at the time of surgery depending on the nature of the repair needed. In general, the surgeon may cut and shape CardioCel to suit the requirements of the procedure. Care needs to be taken when handling the device, for example by using atraumatic forceps, to avoid tearing or otherwise damaging the patch. The device needs to be examined for damage prior to implant. If one side of the patch appears smoother than the other, the device should be implanted with the smoother surface facing the blood flow surface. CardioCel may be cut, folded or layered as required. If layering, it is preferable to cut the material into separate sheets, creating edges rather than folding it, presenting the maximum number of cut surfaces to body tissue, to enhance penetration by cell and blood vessels. CardioCel may be sutured or stapled in place. It will hold sutures easily and firmly and will remain in situ whilst it is incorporated into surrounding tissues. Any unused pieces of CardioCel should be discarded. The solution in which the CardioCel is sterilised/stored should be disposed of using normal hospital chemical waste disposal methods. The surgical procedure time is dependent upon the severity of the condition being treated and any intra-operative complications that may occur. Routinely these type of procedures take approximately two hours.
Intervention code [1] 286755 0
Treatment: Devices
Intervention code [2] 286760 0
Treatment: Surgery
Comparator / control treatment
no control - all patients receive the device
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289107 0
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.
Timepoint [1] 289107 0
Intra-operatively, peri-operatively, 30 days and 12 months
Secondary outcome [1] 301834 0
To evaluate echocardiographic aspect at 30 days and 12 months compared to baseline.
Timepoint [1] 301834 0
The echocardiograph will be performed at 30 days post op and 12 months post op.
Secondary outcome [2] 301835 0
The evaluation of incidence of short and long term calcification of the grated patch and assessment of patch integrity will be by echocardiograph.
Timepoint [2] 301835 0
Evidence of calcification and patch integrity will be confirmed by echocardiograph at 12 months post op.

Eligibility
Key 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
Minimum age
1 Days
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prior to performing any study specific procedure a signed consent form will be obtained for each subject. As subjects are below the legal age, a parent, legal guardian or person with power of attorney must also sign the consent form. The investigator will conduct the informed consent discussion and will check that the subject and their legally acceptable representative comprehend the information provided and answer any questions about the study. Consent will be voluntary and free from coercion. The investigator that conducted the consent discussion will also sign the consent form. A copy will be given to the patient and their representative and the fact that the subject consented to the study will be recorded in the subjects' medical record. When all the inclusion/exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be scheduled for implant and considered enrolled into the Study. As this is a non-randomised trial, all study participants will receive the CardioCel and allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable for this study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
This is a pilot study and analysis will take place on completion of data collected from these patients. There has been no power analysis performed to determine the sample size for this study as it is a pilot study designed to help shape future pivotal studies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/03/2013
Actual
19/07/2013
Date of last participant enrolment
Anticipated
Actual
23/12/2013
Date of last data collection
Anticipated
Actual
2/03/2016
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 782 0
The Royal Childrens Hospital - Parkville

Funding & Sponsors
Funding source category [1] 286915 0
Commercial sector/Industry
Name [1] 286915 0
Celxcel Pty Ltd
Country [1] 286915 0
Australia
Primary sponsor type
Individual
Name
A/Professor Christian Brizard
Address
Director of the Cardiac Surgery Unit
Royal Children's Hospital
50 Flemington Road
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 285704 0
None
Name [1] 285704 0
Address [1] 285704 0
Country [1] 285704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288973 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 288973 0
50 Flemington Road
Parkville Victoria 3052
Ethics committee country [1] 288973 0
Australia
Date submitted for ethics approval [1] 288973 0
Approval date [1] 288973 0
01/02/2013
Ethics approval number [1] 288973 0
32204A

Summary
Brief summary
CardioCel is a new method to prepare and treat biological tissues used in human surgical procedures. This means that the tissue (here bovine pericardium) used to close or repair defects associated with congenital heart disease has not been approved for this purpose in Australia or in other parts of the world. This project is going to allow us to show if the CardioCel integrity is maintained. We believe the CardioCel to be equivalent to currently available patches used to repair congenital heart disease
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38570 0
A/Prof Christian Brizard
Address 38570 0
Director of the Cardiac Surgery Unit
Royal Children's Hospital
50 Flemington Road
Parkville Vic 3052
Country 38570 0
Australia
Phone 38570 0
+61 3 9345 5200
Fax 38570 0
Email 38570 0
[email protected]
Contact person for public queries
Name 38571 0
Christian Brizard
Address 38571 0
Director of the Cardiac Surgery Unit
Royal Children's Hospital
50 Flemington Road
Parkville Vic 3052
Country 38571 0
Australia
Phone 38571 0
+61 3 9345 5200
Fax 38571 0
Email 38571 0
[email protected]
Contact person for scientific queries
Name 38572 0
Christian Brizard
Address 38572 0
Director of the Cardiac Surgery Unit
Royal Children's Hospital
50 Flemington Road
Parkville Vic 3052
Country 38572 0
Australia
Phone 38572 0
+61 3 9345 5200
Fax 38572 0
Email 38572 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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