An observational study in Transposition of Great Vessels, sponsored by University of Zurich. Active, not recruiting at 11 sites in 5 countries. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by University of Zurich · Observational
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.
45 studies on the registry are indexed under Transposition of Great Vessels; 9 are open to participants now.
This study's enrollment of 540 is above the median of 151 across 21 observational studies indexed under Transposition of Great Vessels.
Browse Transposition of Great Vessels studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
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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.
Exclusion Criteria:
Patients with previous arterial switch operation for the treatment of a transposition of great arteries will constitute the sole group of the cohort.
Other: No intervention is planed
No intervention is planed
Incidence of all-cause mortality
Determination of cause of death
Time frame: 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.
Time frame: 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.
Time frame: during a follow up of up to 20 years
Incidence/rate of neo-aortic dissection
Aortic dissection with entry within the neo-aortic root.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: during a follow up of up to 20 years
Rate of right ventricular outflow tract stenosis
At least 1 of the following criteria: * Branch pulmonary artery minimal diameter: maximal diameter at least 1:2 on CT or MRI * Echocardiographic systolic peak gradient across branch pulmonary arteries \> 16mmHg (peak velocity \> 2.0m/s) * Estimated right ventricular systolic pressure \> 40mmHg (determined by RV/RA-pressure gradient and estimated central venous pressure, see echocardiography protocol for details)
Time frame: during a follow up of up to 20 years
Rate of the different patterns of the coronary anatomy
To study the impact of coronary artery anatomy and type of coronary reimplantation on cardiovascular morbidity, ventricular function and functional capacity with a specific focus on presence of coronary artery obstruction, acute proximal angulation and inter-arterial or intramural course.
Time frame: during a follow up of up to 20 years
Incidence/rate of neo-aortic root dilatation
Increase of neo-aortic root dilatation of at least 3mm, determined with the same imaging modality and appropriate side-by-side comparison of actual images.
Time frame: during a follow up of up to 20 years
Incidence of progression of neo-aortic root dilatation
Increase of neo-aortic root dilatation of at least 3mm, determined with the same imaging modality and appropriate side-by-side comparison of actual images.
Time frame: during a follow up of up to 20 years
Incidence/rate of neo-aortic regurgitation
Assessment by echocardiography: - Mild, moderate, severe (50) Assessment by CMR - Regurgitation fraction and volume by flow measurements in proximal aortic root.
Time frame: during a follow up of up to 20 years
Incidence of progression of neo-aortic regurgitation
Increase \> 1 grade (echocardiography) Increase of regurgitant fraction \>10% on CMR.
Time frame: during a follow up of up to 20 years
Incidence/rate of left ventricular systolic dysfunction
Echocardiography: - Left ventricular ejection fraction (LVEF) biplane Simpson \<52% for men and \<54% for women (33) CMR: - LVEF \< 52%
Time frame: during a follow up of up to 20 years
Incidence/rate of left ventricular diastolic dysfunction
Echocardiography: - Defined according to the current recommendations for the evaluation of left ventricular diastolic function by the America society of echocardiography and the European association of cardiovascular Imaging.
Time frame: during a follow up of up to 20 years
Incidence of worsening left ventricular function
Decrease of LVEF \>5%
Time frame: during a follow up of up to 20 years
Incidence/rate of Right ventricular dysfunction
Echocardiography: - At least 2 of the following * FAC \<30% * TAPSE \<18mm * TAPSE S' \<10cm/s CMR: - RVEF \< 50%
Time frame: during a follow up of up to 20 years
Incidence of worsening right ventricular function
Echocardiography (not valid in case of worsening tricuspid regurgitation) - At least 2 of the following: * Decrease in Fac \> 10% * Decrease in TAPSE \>5mm * Decrease in TAPSE S' \>3cm/s CMR: - Decrease in RVEF \>5%
Time frame: during a follow up of up to 20 years
Rate of poor functional capacity
As determined by cardiopulmonary exercise testing by measuring Lung Function (flow volume loops), oxygen consumption during exercise (VO2 max), anaerobic threshold, heart performance during exercise (O2-Heart rate)
Time frame: during a follow up of up to 20 years
Incidence of pregnancy
To study the impact of pregnancy on mortality and cardiovascular morbidity.
Time frame: during a follow up of up to 20 years
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Plan to share: No
This study is active, not recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Transposition of Great Vessels→
University of Zurich