NCT03207373

Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With WPW Pattern

Terminated NA Last updated 1 February 2024

What this trial tests

NA trial testing Stress test (ECG) in Wolff-Parkinson-White Syndrome in 3 participants. Terminated before completion.

Timeline

13 April 2017

Primary endpoint
30 January 2024

30 January 2024

Quick facts

Lead sponsor	Christian Balmer
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	3
Start date	13 April 2017
Primary completion	30 January 2024
Estimated completion	30 January 2024
Sites	1 location across Switzerland

Drugs / interventions tested

• Stress test (ECG)

Conditions studied

• Wolff-Parkinson-White Syndrome — all drugs for Wolff-Parkinson-White Syndrome →
• Sudden Cardiac Death — all drugs for Sudden Cardiac Death →
• Risk Stratification — all drugs for Risk Stratification →

Sponsor

Christian Balmer

Who can join

Adults 8 to 18, any sex, with Wolff-Parkinson-White Syndrome or Sudden Cardiac Death. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with preexcitation are at risk for sudden cardiac death. The pathogenesis is a rapid antegrade conduction of atrial fibrillation over the accessory pathway to the ventricle resulting in ventricular fibrillation. Today it is possible to eliminate the conduction over the accessory pathway by catheter intervention (radiofrequency ablation) with a low rate of complications and a high rate of success. In clinical practice it is therefore important to estimate the risk for sudden cardiac death in an individual patient to give an advice to the patient and the parents about the further evaluation and therapeutic strategy. The velocity of the conduction over the accessory pathway can be estimated by analysing the ECG during sinus tachycardia. If the preexcitation disappears at a relatively low heart rate, the risk for sudden death is less than in patients with persisting preexcitation at the maximal heart rate. Compared to the gold standard i.e. measurement of the refractory period of the accessory pathway during invasive electrophysiological study (EPS), the measurements at the stress ECG have been reported to be a relatively poor indicator for an elevated risk which may be explained by a high intraindividual variability of this test. This study is designed to define the clinical relevance of the stress ECG in paediatric patients with preexcitation (compared to the invasive electrophysiological study).

First Hypothesis:

The results of the 3 stress ECG-tests are reproducible in an individual patient.

Null hypothesis: there is no difference between the three measurements of cycle length during stress ECG. Alternate hypothesis: the difference between the three measurements of cycle length is \> 10%.

Second Hypothesis:

There is a close correlation between the results at stress ECG and the results at the invasive electrophysiological Intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.