search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Observational study for CardioCel


- candidate number27079
- NTR NumberNTR6437
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-apr-2017
- Secondary IDsCC-06 - Admedus Regen Pty Ltd 46/17 S - EC van de Technical University Munich
- Public TitleObservational study for CardioCel
- Scientific TitleEuropean Registry Program for the Use of CardioCel in Cardiac Septal Defects, and Valve and Annulus Repair
- ACRONYM
- hypothesisThere is no formal statistical hypothesis to be tested in this Registry program.
- Healt Condition(s) or Problem(s) studiedValve disease, Valve surgery,
- Inclusion criteriaPatients 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 criteriaThis Registry Program does not focus on patients with injured myocardial tissue.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-apr-2017
- planned closingdate
- Target number of participants200
- InterventionsNA
- Primary outcomeThe 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 outcomeNA
- TimepointsNA
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Annelies van Mourik
- CONTACT for SCIENTIFIC QUERIES Jurriaan Sombeek
- Sponsor/Initiator Admedus Regen Pty Ltd
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD12-apr-2017 - 27-aug-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl