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NCT04335448

Comprehensive Long-term Follow up of Adults With Arterial Switch Operation

Sponsor: University of Zurich

View on ClinicalTrials.gov

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

Interventions

OTHER

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