No registrations found.
ID
Source
Health condition
Patients requiring repair of valves and annulus and cardiac septal defects including atrial septal defects, ventricular septal defects and atrioventricular defects.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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:
o Desired haemodynamics achieved
o Patch dehiscence
o Patch thickening
o Patch retraction
The secondary endpoint of the Registry Program is user satisfaction as evaluated during implantation surgery by the surgeon.
Secondary outcome
NA
Background summary
The CardioCel Registry Program provides Admedus Regen Pty Ltd
with an opportunity to collect prospective and retrospective, real-
world product usage and safety data on patients treated with
CardioCel post-CE Mark. This information serves to formulate and
sustain sound safety, scientific, clinical, quality, reimbursement,
and marketing objectives.
Study objective
There is no formal statistical hypothesis to be tested in this Registry program.
Study design
NA
Intervention
NA
Prof. Bronkhorstlaan 10 (gebouw 54),
Bilthoven 3723 MB
The Netherlands
+31 229 2727 (extensie 110)
A.vanMourik@factory-cro.com
Prof. Bronkhorstlaan 10 (gebouw 54),
Bilthoven 3723 MB
The Netherlands
+31 229 2727 (extensie 110)
A.vanMourik@factory-cro.com
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6263 |
| NTR-old | NTR6437 |
| Other | 46/17 S - EC van de Technical University Munich : CC-06 - Admedus Regen Pty Ltd |