Pulmonary atresia with intact ventricular septum: long term follow-up after biventricular vs. univentricular correctio

• Conditions: cardiac reserve; cardiac response to exercise; 10010394; 10007510

• Registration Number: NL-OMON31965
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Treated pulmonary atresia with intact ventricular septum
Age > 8 yrs
No contra-indication for exercise test such as severe aortic-valve stenosis
No contra-indication for MRI examination, such pace maker dependency, cardiac arrhythmia*s or claustrophobia
No contra-indication for Dobutamin, such as prior allergic reaction or cardiac arrhytmias
No contra-indication for contrast agent, such as prior allergic reaction or renal disease

Exclusion Criteria

Contra-indications for exercisetest, dobutamine, MRI-scan
Mental retardation

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this study are<br /><br>1- cardiac reserve, measured as percentual increase in CO or EF<br /><br>2- Clinical outcome, indicated as a common endpoint including number of<br /><br>hospital admissions and occurrence of arrhythmia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are :<br /><br>1)VO2 max<br /><br>2) Quality of Life score<br /><br>3) Brain natriuretic peptide levels<br /><br>4) RV function<br /><br>5) LV function<br /><br>6) Extent of myocardial scar </p><br>