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Comprehensive Long-term Follow up of Adults With Arterial Switch Operation
Sponsor: University of Zurich
Summary
Background: Long-term outcomes in adults with prior arterial switch operation (ASO) have not yet been well defined. The aim of this study is to elucidate incidence and predictors of adverse cardiac outcomes in a prospectively followed cohort of adults after their ASO. Methods: The comprehensive long-term follow up of adults with ASO is a project within the European collaboration for prospective outcome research in congenital heart disease (EPOCH). It is designed as a prospective, international multicenter cohort study. Consecutive patients (aged 16 years or more) with prior ASO will be included at 11 European tertiary care centers. Participants will be followed according to a standardized protocol following international recommendations, including standardized protocols for imaging and for exercise testing. Main outcome measures are all-cause and cardiac-related mortality, rate of cardiac re-intervention, neo-aortic dissection, myocardial infarction, stroke, infective endocarditis, sustained atrial and ventricular arrhythmias, new-onset or worsening pulmonary hypertension and new-onset heart failure. Secondary endpoints are frequency and progression of right ventricular outflow tract stenosis, neo-aortic root dilatation, neo-aortic valve regurgitation and ventricular dysfunction. The impact of demographic, anatomic (e.g. coronary artery anatomy) and functional variables on the above-mentioned outcomes, as well as quality of life and incidence of pregnancy related complications will also be assessed. Aim: The prospective, international, multicenter EPOCH-ASO study will provide a better understanding of adverse outcomes and their predictors in adults after ASO. The results of the EPOCH-ASO study may help to optimize future care of this novel patient cohort in adult cardiology.
Official title: Comprehensive Long-term Follow up of Adults With Arterial Switch Operation - European Collaboration for Prospective Outcome Research in Congenital Heart Disease
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
OBSERVATIONAL
Enrollment
540
Start Date
2019-10-01
Completion Date
2039-09-30
Last Updated
2022-11-08
Healthy Volunteers
Yes
Conditions
Interventions
No intervention is planed
No intervention is planed
Locations (11)
University Hospital Vienna
Vienna, Austria
CHU Paris IdF Ouest - HEGP Hôpital Européen Georges Pompidou
Paris, France
Amsterdam University Medical Center
Amsterdam, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Universitario y Politécnico La Fe Valencia
Valencia, Spain
University Hospital Basel
Basel, Switzerland
University Hospital Inselspital Bern
Bern, Switzerland
University Hospital Geneva
Geneva, Switzerland
University Hospital Lausanne
Lausanne, Switzerland
University Hospital Zurich
Zurich, Switzerland