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

NCT04335448 | Active Not Recruiting

• 1 other identifier: EPOCH
• Study Type: observational
• Target: 540
• Locations: 5 countries
• Sites: 11

Brief 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.

Conditions

Transposition of Great Vessels

Keywords

transposition of the great arteries; arterial switch operation; coronary artery anomaly; outcome

Outcome Measures

Primary Outcomes (10)

• 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.

  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

Secondary Outcomes (13)

• 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

Study Arms (1)

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.

Other: No intervention is planed

Interventions

No intervention is planed OTHER

No intervention is planed

Arterial Switch Operation - Transposition of Great Arteries

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Incapability of giving informed consent and previous heart transplant.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (11)

University Hospital Vienna

Vienna, Austria

Location

CHU Paris IdF Ouest - HEGP Hôpital Européen Georges Pompidou

Paris, France

Location

Amsterdam University Medical Center

Amsterdam, Netherlands

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Hospital Universitario y Politécnico La Fe Valencia

Valencia, Spain

Location

University Hospital Basel

Basel, Switzerland

Location

University Hospital Inselspital Bern

Bern, Switzerland

Location

University Hospital Geneva

Geneva, Switzerland

Location

University Hospital Lausanne

Lausanne, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40701798 DERIVED

MeSH Terms

Conditions

Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Matthias Greutmann, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD. Dr. med.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 6, 2020
• Study Start: October 1, 2019
• Primary Completion (Estimated): September 30, 2039
• Study Completion (Estimated): September 30, 2039
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); NL (1); AU (1); CH (5); FR (1)