Evaluation of the VU-AMS device during follow-up of children with congenital heart disease

Evaluation of the VU-AMS device during follow-up of children with congenital heart disease - Evaluation of the VU-AMS device in congenital heart disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40526

Enrollment

120

Registered

2014-06-16

Start date

2015-06-15

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Congenital heart disease heart disease

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Patients after repair of a ventricular septal defect (VSD), patients after coarctectomy, patients after arterial switch operation for transposition of the great arteries, patients with a univentricular heart after Fontan completion.

Exclusion criteria

Exclusion criteria: Comorbidity

Design outcomes

Primary

Measure	Time frame
The most important study variables are: Stroke volume (SV): the amount of blood leaving the heart with a single heartbeat. Pre Ejection Period (PEP); The time between the onset of the electrical activation of the ventricles and the mechanical activation of the ventricles (opening of the aortic valve). This is a measure of sympathetic activity and contractility of the heart muscle. Respiratory sinus arrhythmia (RSA); this is a naturally occurring variation in heart frequency during a breathing cycle. RSA is the difference in time between the shortest two successive heart beats and the slowest. Left ventricular enddiastolic volume as measured by echocardiography and MRI Maximal oxygen consumption as measured by a maximal exercise test	—

Measure

Time frame

The most important study variables are: Stroke volume (SV): the amount of blood leaving the heart with a single heartbeat. Pre Ejection Period (PEP); The time between the onset of the electrical activation of the ventricles and the mechanical activation of the ventricles (opening of the aortic valve). This is a measure of sympathetic activity and contractility of the heart muscle. Respiratory sinus arrhythmia (RSA); this is a naturally occurring variation in heart frequency during a breathing cycle. RSA is the difference in time between the shortest two successive heart beats and the slowest. Left ventricular enddiastolic volume as measured by echocardiography and MRI Maximal oxygen consumption as measured by a maximal exercise test

—

Secondary

Measure	Time frame
None.	—

Countries

Netherlands

Outcome results