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

NCT03207373 | Terminated

• 1 other identifier: 2016-01943
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wolff-Parkinson-White Syndrome; Sudden Cardiac Death; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• Cycle length (CL) at the Stress ECG Test

  Cycle length (ms) at the point when the delta wave disappears and/or at the point of maximal heart rate (HR) (ms)

  3 test within a month

Secondary Outcomes (3)

• ERP-AP from invasive EPS

  1 single measurement at aprox 1 month

• SPERRI from invasive EPS

  1 single measurement at aprox 1 month

• Anatomical localisation of the AP measured in the EPS

  1 single measurement at aprox 1 month

Other Outcomes (11)

• Heart rate of 12-lead Resting ECG

  1 single measurement within 1 month

• Rhythm during 12-lead Resting ECG

  1 single measurement within 1 month

• axis of the QRS complex out of the 12-lead Resting ECG

  1 single measurement within 1 month

Study Arms (1)

Stress ECG Test

EXPERIMENTAL

The whole study cohort undergoes the same diagnostic workup including stress test (ECG)

Diagnostic Test: Stress test (ECG)

Interventions

Stress test (ECG) DIAGNOSTIC_TEST

Every study participant undergoes a standard diagnostic stress ECG

Stress ECG Test

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Preexcitation in resting ECG (WPW ECG Pattern)
• Age between 8 and 18 years
• Invasive EPS must be indicated/planned at the Children's Hospital Zurich

You may not qualify if:

• Inability to follow the procedures of the study, e.g. due to language problems or psychological disorders of the participant
• Inability to walk/run on a treadmill

Sponsors & Collaborators

• Christian Balmer: lead

Study Sites (1)

University Childrens Hospital

Zurich, 8090, Switzerland

Location

MeSH Terms

Conditions

Wolff-Parkinson-White Syndrome; Death, Sudden, Cardiac

Interventions

Exercise Test; Electrocardiography

Condition Hierarchy (Ancestors)

Pre-Excitation Syndromes; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Electrodiagnosis

Study Officials

• Christian Balmer, PD Dr. med.

  University Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Electrophysiology, principal investigator, clinical lecturer

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: July 2, 2017
• Study Start: April 13, 2017
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)