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EPOCH-ASO
Sponsor study identifier
observational
540
5 countries
11
Study Start
October 1, 2019
Actual (reported)Primary Completion
September 30, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2019
Actual (reported)March 23, 2020
Actual (reported)April 6, 2020
Actual (reported)September 30, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of all-cause mortality
Determination of cause of death
during a follow up of up to 20 years
Incidence of cardiac-related mortality
Sudden cardiac death (death that ensues unexpected within one hour of onset of symptoms), death related to acute myocardial infarction, death that is primarily caused by heart failure or death within 30 days or during the hospital admission after a cardiac intervention.
during a follow up of up to 20 years
Incidence/rate of re-intervention
Includes all types of cardiac re-intervention with detailed analysis of the indication of re-intervention.
during a follow up of up to 20 years
Incidence/rate of neo-aortic dissection
Aortic dissection with entry within the neo-aortic root.
during a follow up of up to 20 years
Incidence of myocardial infarction
Defined according to the Fourth Universal Definition of Myocardial Infarction. Defined according to the Fourth Universal Definition of Myocardial Infarction.
Rate of right ventricular outflow tract stenosis
during a follow up of up to 20 years
Rate of the different patterns of the coronary anatomy
during a follow up of up to 20 years
Incidence/rate of neo-aortic root dilatation
during a follow up of up to 20 years
Incidence of progression of neo-aortic root dilatation
during a follow up of up to 20 years
Incidence/rate of neo-aortic regurgitation
during a follow up of up to 20 years
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adults (≥16 years) 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 are incapability of giving informed consent and previous heart transplant.
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
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. 2026 Mar 25;112(8):437-445. doi: 10.1136/heartjnl-2024-325634.
Matthias Greutmann, MD
University of Zurich
540 participants (actual enrollment reported by the registry).
First Submitted
March 23, 2020
First Posted
April 6, 2020
Study Start
October 1, 2019
Actual (reported)during a follow up of up to 20 years
Incidence of arrhythmias
Atrial arrhythmias with a duration of \>30 seconds, or requiring anti-arrhythmic medication or ablation procedures and / or sustained ventricular tachycardia (heart rate \>100/min) for at least 30 seconds or requiring electrical cardioversion / defibrillation.
during a follow up of up to 20 years
Incidence of new onset / worsening heart failure
Hospital admission for heart failure or initiation of heart failure medication for symptoms of heart failure (excludes initiation of medication for asymptomatic deterioration of ventricular function), according to the current guidelines of the European Society of Cardiology.
during a follow up of up to 20 years
Incidence of stroke
Focal neurological symptoms and confirmation of cerebral ischemia or infarction by cerebral magnetic resonance imaging or computed tomography.
during a follow up of up to 20 years
Incidence of infective endocarditis
Defined according to the modified Duke's criteria, according to the current ESC guidelines.
during a follow up of up to 20 years
Incidence of pulmonary hypertension
Defined as an increase in mean pulmonary arterial pressure (PAPm) ≥20 mmHg at rest as assessed by right heart catheterization.
during a follow up of up to 20 years
Contact the study team to confirm eligibility.
University Hospital Inselspital Bern
Bern, Switzerland
University Hospital Geneva
Geneva, Switzerland
University Hospital Lausanne
Lausanne, Switzerland
University Hospital Zurich
Zurich, Switzerland
Primary Completion
September 30, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2039
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 8, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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