There is no formal statistical hypothesis to be tested in this Registry program.
ID
Bron
Aandoening
Patients requiring repair of valves and annulus and cardiac septal defects including atrial septal defects, ventricular septal defects and atrioventricular defects.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoints of the Registry Program are:<br>
• Occurrence of device related safety events, including unexpected or rare events<br>
• Device performance, as documented by interpretation of echocardiography:<br>
o Desired haemodynamics achieved<br>
o Patch dehiscence<br>
o Patch thickening<br>
o Patch retraction <br>
The secondary endpoint of the Registry Program is user satisfaction as evaluated during implantation surgery by the surgeon.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
There is no formal statistical hypothesis to be tested in this Registry program.
Onderzoeksopzet
NA
Onderzoeksproduct en/of interventie
NA
Publiek
Prof. Bronkhorstlaan 10 (gebouw 54),
Bilthoven 3723 MB
The Netherlands
+31 229 2727 (extensie 110)
A.vanMourik@factory-cro.com
Wetenschappelijk
Prof. Bronkhorstlaan 10 (gebouw 54),
Bilthoven 3723 MB
The Netherlands
+31 229 2727 (extensie 110)
A.vanMourik@factory-cro.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
This Registry Program does not focus on patients with injured myocardial tissue.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6263 |
| NTR-old | NTR6437 |
| Ander register | 46/17 S - EC van de Technical University Munich : CC-06 - Admedus Regen Pty Ltd |