Comprehensive Long-term Follow up of Adults With Arterial Switch Operation
NCT ID: NCT04335448
Last Updated: 2022-11-08
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
540 participants
OBSERVATIONAL
2019-10-01
2039-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arterial Switch Operation - Transposition of Great Arteries
Patients with previous arterial switch operation for the treatment of a transposition of great arteries will constitute the sole group of the cohort.
No intervention is planed
No intervention is planed
Interventions
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No intervention is planed
No intervention is planed
Eligibility Criteria
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Inclusion Criteria
* with transposition of great arteries or a Taussig-Bing anomaly
* who underwent repair by an ASO, and who are actively followed at one of the participating centers will be enrolled.
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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University of Zurich
OTHER
Responsible Party
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Matthias Greutmann
PD. Dr. med.
Principal Investigators
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Matthias Greutmann, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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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
Countries
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References
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Ruperti-Repilado FJ, Ladron R, Lopez-Ayala P, Gabra B, Gonzalez-Fernandez V, Engele LJ, Manso B, Bouma BJ, Gabriel H, Schwitz F, Possner M, Schwerzmann M, Rueda J, Buendia-Fuentes F, Bouchardy J, Ladouceur M, Dos-Subira L, Greutmann M, Tobler D, Gallego P. Aortic coarctation and long-term morbidity after arterial switch operation: a multicentre international cohort study. Heart. 2025 Jul 23:heartjnl-2024-325634. doi: 10.1136/heartjnl-2024-325634. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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EPOCH
Identifier Type: -
Identifier Source: org_study_id
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