Patients requiring repair of valves and annulus and cardiac septal defects including atrial septal defects, ventricular septal defects and atrioventricular defects.
Conditions
Interventions
None listed
Sponsors
Admedus Regen Pty Ltd
Eligibility
Inclusion criteria
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
Exclusion criteria: This Registry Program does not focus on patients with injured myocardial tissue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the Registry Program are: •Occurrence of device related safety events, including unexpected or rare events •Device performance, as documented by interpretation of echocardiography: oDesired haemodynamics achieved oPatch dehiscence oPatch thickening oPatch retraction The secondary endpoint of the Registry Program is user satisfaction as evaluated during implantation surgery by the surgeon. | — |
Contacts
Public ContactAnnelies van Mourik
Outcome results
None listed