PREpArE-Fontan registry
Research type
Research Study
Full title
Patient REgistry for AdolescEnts and Adults with Stable Fontan Circulation
IRAS ID
192531
Contact name
Paul Clift
Contact email
Sponsor organisation
ACTELION Pharmaceuticals Ltd
Clinicaltrials.gov Identifier
D-15.503, Document number
Duration of Study in the UK
1 years, 1 months, 17 days
Research summary
PREpArE-Fontan registry is an international, multicenter,cross-sectional, non-interventional (observational)study. This study is taking place at a number of locations in various countries in Europe. It will capture information regarding data on adolescent and adult ‘stable’ patients after the modern type of Fontan surgery at least 10 years post-Fontan completion.
During a 1-year enrolment period, consecutive patients meeting the selection criteria will be asked whether they want to participate in the registry. As the study is cross-sectional, there will be only one registration visit for each participating patient, and data will be collected only once at that single visit. There will be no follow-up. As the study is observational, no assessments will be requested other than the ones the physicians collect as per routine clinical practice.
Patient data will be abstracted from the patients’ medical charts and from data collected during the registration visit.REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0770
Date of REC Opinion
11 Mar 2016
REC opinion
Further Information Favourable Opinion