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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31965

Enrollment

Registered

2008-07-15

Start date

2008-05-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac reserve cardiac response to exercise

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Contra-indications for exercisetest, dobutamine, MRI-scan Mental retardation

Design outcomes

Primary

Measure	Time frame
The primary endpoints of this study are 1- cardiac reserve, measured as percentual increase in CO or EF 2- Clinical outcome, indicated as a common endpoint including number of hospital admissions and occurrence of arrhythmia.	—

Secondary

Measure	Time frame
Secondary endpoints are : 1)VO2 max 2) Quality of Life score 3) Brain natriuretic peptide levels 4) RV function 5) LV function 6) Extent of myocardial scar	—

Countries

Netherlands

Outcome results