ong-term clinical follow-up including cardiac imaging and functional diagnostics in adults after neonatal arterial switch surgery at the Children's Heart Center of the University Hospital Aachen for transposition of the great arteries

• Conditions: Q20.3; Discordant ventriculoarterial connection

• Registration Number: DRKS00031568
• Lead Sponsor: niversitätsklinikum Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adult EMAH patients who underwent arterial switch surgery for D-transposition of the great arteries with or without ventricular septal defect in the neonatal period at the University Hospital of RWTH Aachen University.
- Dto, with possible two-stage surgical correction of aortic isthmic stenosis in the neonatal or pediatric period.

Exclusion Criteria

- under 18 years
- Persons who are deprived of their liberty on the basis of an official order or a court order or approval.
- There are no further general exclusion criteria for the cohort register.
Clinical contraindications may exist for individual study components, which lead to the non-performance of certain studies:
- If pregnancy is present (verbal query at invitation and study inclusion), inclusion in the study is not currently possible.
- Inclusion in the study may be possible at a later date.
- If the patient has already been included in the observational study, an examination outside the scope of the cohort study may be performed for clinical reasons during the pregnancy. Individual medical care independent of the study is of course possible at any time during pregnancy or breastfeeding.
- Patients with contraindications against an MRI examination (e.g. non-MRI capable pacemaker or defibrillator, certain metallic implants, severe claustrophobia) will not undergo an MRI examination.
- Patients with contraindications to MRI contrast agent use (severe renal insufficiency with a glomerular filtration rate below 30 ml/min, known gadolinium contrast agent allergy) will not have MRI contrast agent administration. If necessary, an MRI examination without contrast medium is advisable. This will be discussed with you individually.
- In patients with contraindications to adenosine/regadenosone or dobutamine stress (e.g., high-grade aortic stenosis, uncontrolled hypertension, acute or unstable angina pectoris symptoms), a stress examination with the respective stress drug is not performed.
- Patients with contraindications to a CT contrast agent examination (known allergy to iodine-containing X-ray contrast agents, impaired kidney function, hyperthyroidism) will not undergo a CT examination.
- Patients with physical disabilities or chronic diseases that make spiroergometric examination impossible are not examined spiroergometrically.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
no primary endpoint defined:<br>On the basis of a high number of homogeneous patients, the study enables an assessment of the surgical method in the long-term course and the assessment of the cardiac risk for patients in young and progressive adulthood. not applicable

Secondary Outcome Measures

Name	Time	Method
not applicable