Observational study for CardioCel
- Conditions
- Patients requiring repair of valves and annulus and cardiac septal defects including atrial septal defects, ventricular septal defects and atrioventricular defects.
- Registration Number
- NL-OMON26419
- Lead Sponsor
- Admedus Regen Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Patients requiring repair of valves and annulus and cardiac septal defects including atrial septal defects, ventricular septal defects and atrioventricular defects. The majority of participating subjects will be paediatrics, since the indication concerns congenital cardiac defects.
Exclusion Criteria
This Registry Program does not focus on patients with injured myocardial tissue.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints of the Registry Program are:<br /><br>•Occurrence of device related safety events, including unexpected or rare events<br /><br>•Device performance, as documented by interpretation of echocardiography:<br /><br>oDesired haemodynamics achieved<br /><br>oPatch dehiscence<br /><br>oPatch thickening<br /><br>oPatch retraction <br /><br>The secondary endpoint of the Registry Program is user satisfaction as evaluated during implantation surgery by the surgeon.<br>
- Secondary Outcome Measures
Name Time Method