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

Completed

• Conditions: Congenital heart disease; heart disease; 10010394; 10007510

• Registration Number: NL-OMON40526
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

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

Comorbidity

Study & Design

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>None.</p><br>