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NCT Number: NCT04335448

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Transposition of Great Vessels Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Vienna, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Incapability of giving informed consent and previous heart transplant.

Treatment and study plan

No intervention is planed

Other

No intervention is planed

Primary outcomes

  1. Incidence of all-cause mortality

    Time frame: during a follow up of up to 20 years

    Determination of cause of death

  2. Incidence of cardiac-related mortality

    Time frame: during a follow up of up to 20 years

    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.

  3. Incidence/rate of re-intervention

    Time frame: during a follow up of up to 20 years

    Includes all types of cardiac re-intervention with detailed analysis of the indication of re-intervention.

  4. Incidence/rate of neo-aortic dissection

    Time frame: during a follow up of up to 20 years

    Aortic dissection with entry within the neo-aortic root.

  5. Incidence of myocardial infarction

    Time frame: during a follow up of up to 20 years

    Defined according to the Fourth Universal Definition of Myocardial Infarction. Defined according to the Fourth Universal Definition of Myocardial Infarction.

  6. Incidence of arrhythmias

    Time frame: during a follow up of up to 20 years

    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.

  7. Incidence of new onset / worsening heart failure

    Time frame: during a follow up of up to 20 years

    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.

  8. Incidence of stroke

    Time frame: during a follow up of up to 20 years

    Focal neurological symptoms and confirmation of cerebral ischemia or infarction by cerebral magnetic resonance imaging or computed tomography.

  9. Incidence of infective endocarditis

    Time frame: during a follow up of up to 20 years

    Defined according to the modified Duke's criteria, according to the current ESC guidelines.

  10. Incidence of pulmonary hypertension

    Time frame: during a follow up of up to 20 years

    Defined as an increase in mean pulmonary arterial pressure (PAPm) ≥20 mmHg at rest as assessed by right heart catheterization.

Secondary outcomes

  1. Rate of right ventricular outflow tract stenosis

    Time frame: during a follow up of up to 20 years

    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)

  2. Rate of the different patterns of the coronary anatomy

    Time frame: during a follow up of up to 20 years

    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.

  3. Incidence/rate of neo-aortic root dilatation

    Time frame: during a follow up of up to 20 years

    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.

  4. Incidence of progression of neo-aortic root dilatation

    Time frame: during a follow up of up to 20 years

    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.

  5. Incidence/rate of neo-aortic regurgitation

    Time frame: during a follow up of up to 20 years

    Assessment by echocardiography:

    • Mild, moderate, severe (50)

    Assessment by CMR

    • Regurgitation fraction and volume by flow measurements in proximal aortic root.

  6. Incidence of progression of neo-aortic regurgitation

    Time frame: during a follow up of up to 20 years

    Increase > 1 grade (echocardiography) Increase of regurgitant fraction >10% on CMR.

  7. Incidence/rate of left ventricular systolic dysfunction

    Time frame: during a follow up of up to 20 years

    Echocardiography:

    • Left ventricular ejection fraction (LVEF) biplane Simpson <52% for men and <54% for women (33)

    CMR:

    • LVEF < 52%

  8. Incidence/rate of left ventricular diastolic dysfunction

    Time frame: during a follow up of up to 20 years

    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.

  9. Incidence of worsening left ventricular function

    Time frame: during a follow up of up to 20 years

    Decrease of LVEF >5%

  10. Incidence/rate of Right ventricular dysfunction

    Time frame: during a follow up of up to 20 years

    Echocardiography:

    • At least 2 of the following
    • FAC <30%
    • TAPSE <18mm
    • TAPSE S' <10cm/s

    CMR:

    • RVEF < 50%

  11. Incidence of worsening right ventricular function

    Time frame: during a follow up of up to 20 years

    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%

  12. Rate of poor functional capacity

    Time frame: during a follow up of up to 20 years

    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)

  13. Incidence of pregnancy

    Time frame: during a follow up of up to 20 years

    To study the impact of pregnancy on mortality and cardiovascular morbidity.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Comprehensive Long-term Follow up of Adults With Arterial Switch Operation - European Collaboration for Prospective Outcome Research in Congenital Heart Disease

Acronym: EPOCH-ASO

Important dates

Study start
2019
Primary completion
2039
Study completion
2039
First posted
Apr 6, 2020
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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