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

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Brief Title

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

Official Title

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

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.
    



Study Type

Observational [Patient Registry]


Primary Outcome

Incidence of all-cause mortality

Secondary Outcome

 Rate of right ventricular outflow tract stenosis

Condition

Transposition of Great Vessels

Intervention

No intervention is planed

Study Arms / Comparison Groups

 Arterial Switch Operation - Transposition of Great Arteries
Description:  Patients with previous arterial switch operation for the treatment of a transposition of great arteries will constitute the sole group of the cohort.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

700

Start Date

April 2020

Completion Date

September 30, 2039

Primary Completion Date

September 30, 2039

Eligibility Criteria

        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.
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Matthias Greutmann, MD, +41 44 255 38 83, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT04335448

Organization ID

EPOCH


Responsible Party

Principal Investigator

Study Sponsor

University of Zurich


Study Sponsor

Matthias Greutmann, MD, Principal Investigator, University of Zurich


Verification Date

April 2020