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Trial record 3 of 4 for:    "Wolff-Parkinson-White syndrome" OR "Pre-Excitation Syndrome"

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

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ClinicalTrials.gov Identifier: NCT03207373
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2017
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Christian Balmer, University Children's Hospital, Zurich

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.


Condition or disease Intervention/treatment Phase
Wolff-Parkinson-White Syndrome Sudden Cardiac Death Risk Stratification Diagnostic Test: Stress test (ECG) Not Applicable

Detailed Description:

Single centre, interventional study. There will be no randomisation or blinding.

This study evaluates the stress ECG test as a non-invasive method of risk stratification in patients with WPW syndrome. For the non-invasive part a stress electrocardiogram on a treadmill is used. The invasive comparison is made with an electrophysiological study (EPS) in the catheterization laboratory. Nowadays the gold standard for measuring the antegrade effective refractory period of the accessory pathway is the invasive EPS.

Study category A; there is only a minimal risk and a minimal burden to the study participants; The stress ECG test is a recommended test for this specific patient group as indicated in international guidelines.

The responsible investigator at the single study site ensures that approval from an appropriately constituted Competent Ethics Committee (CEC), is sought for the clinical study.

Objectives: 1) The study seeks primarily to evaluate the reproducibility of the loss of the preexcitation in repetitive stress ECG test in paediatric patients with WPW pattern in the view of an accurate estimation of the individual risk for sudden cardiac death.

2) To compare the results of non-invasive ECG measurements with measurements taken during invasive EPS and clinical/anatomical parameters.

Planned Analysis: Descriptive statistic is applied to all clinical parameters. All the 3 cycle lengths out of the stress ECG are compared individually with the ERP-AP from the invasive EPS. If there is an average from the cycle length, this would be compared with the ERP-AP as well. And then we compare whether the difference between the cycle length and the ERP-AP is similar in a group of patients (high/low risk) or even in all patients.

To demonstrate those results we use the Bland-Altman plot. There will also be a graph with the distribution of age of all patients. It will be interesting to see whether the age influences the results for example in relation to high or low risk.

After the EPS, the patients are divided into 2 risk categories: high risk (ERP-AP ≤ 250 ms) and low risk (ERP-AP > 250ms) as measured at the EPS.

At the end a risk factor analysis is made. All the parameters out of the case report form will be analysed whether the patient has high or low risk.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Reproducibility and Validity of the Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With Preexcitation (WPW Pattern)
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stress ECG Test
The whole study cohort undergoes the same diagnostic workup including stress test (ECG)
Diagnostic Test: Stress test (ECG)
Every study participant undergoes a standard diagnostic stress ECG




Primary Outcome Measures :
  1. Cycle length (CL) at the Stress ECG Test [ Time Frame: 3 test within a month ]
    Cycle length (ms) at the point when the delta wave disappears and/or at the point of maximal heart rate (HR) (ms)


Secondary Outcome Measures :
  1. ERP-AP from invasive EPS [ Time Frame: 1 single measurement at aprox 1 month ]
    Effective Refractory Period of Accessory Pathways (ERP-AP) during programmed atrial pacing (ms)

  2. SPERRI from invasive EPS [ Time Frame: 1 single measurement at aprox 1 month ]
    Shortest pre excited Interval between two cardiac cycles (SPERRI)

  3. Anatomical localisation of the AP measured in the EPS [ Time Frame: 1 single measurement at aprox 1 month ]
    leftsided (superior, posterosuperior, posterior, posteroinferior, inferior) or rightsided (paraseptal, inferior, anteroinferior, anterior, anterosuperior and superior)


Other Outcome Measures:
  1. Heart rate of 12-lead Resting ECG [ Time Frame: 1 single measurement within 1 month ]
    (bpm)

  2. Rhythm during 12-lead Resting ECG [ Time Frame: 1 single measurement within 1 month ]
    sinus rhythm yes/no

  3. axis of the QRS complex out of the 12-lead Resting ECG [ Time Frame: 1 single measurement within 1 month ]
    (degree)

  4. Duration of PQ Interval out of the 12-lead Resting ECG [ Time Frame: 1 single measurement within 1 month ]
    (ms)

  5. Duration of the QRS complex (ms) out of the 12-lead Resting ECG [ Time Frame: 1 single measurement within 1 month ]
    (ms)

  6. Z-value of left ventricle (LV) out of Echocardiography [ Time Frame: 1 single measurement at aprox 1 month ]
    Z-value LV

  7. Z-value of right ventricle (RV) out of Echocardiography [ Time Frame: 1 single measurement within 1 month ]
    Z-value RV

  8. Z-value of left Atrium (LA) out of Echocardiography [ Time Frame: 1 single measurement within 1 month ]
    Z-value LA

  9. Shortening fraction (SF) measured in Echocardiography [ Time Frame: 1 single measurement within 1 month ]
    SF (%)

  10. Ejection fraction (EF) measured in Echocardiography 5 [ Time Frame: 1 single measurement within 1 month ]
    EF (%)

  11. Valvular insufficiency measured in Echocardiography [ Time Frame: 1 single measurement within 1 month ]
    aorta-, pulmonal-, tricuspidal-, mitral insufficiency (no, minimal, moderate, severe)



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207373


Locations
Switzerland
University Childrens Hospital
Zurich, Switzerland, 8090
Sponsors and Collaborators
Christian Balmer
Investigators
Principal Investigator: Christian Balmer, PD Dr. med. University Childrens Hospital

Responsible Party: Christian Balmer, Head of Electrophysiology, principal investigator, clinical lecturer, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03207373     History of Changes
Other Study ID Numbers: 2016-01943
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Wolff-Parkinson-White Syndrome
Pre-Excitation Syndromes
Death
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Arrhythmias, Cardiac
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities