Wolff-Parkinson-White SyndromeNCT03207373
Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With WPW Pattern
A study testing Stress test (ECG) in people with Wolff-Parkinson-White Syndrome and Sudden Cardiac Death, run by Christian Balmer at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Wolff-Parkinson-White Syndrome, Sudden Cardiac Death, Risk Stratification
- What is being tested?
- Stress test (ECG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Apr 2017to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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:
Read more
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.
Read the 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.
- 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.
- Being tested
- Stress test (ECG)
- Medical subject headings
- Wolff-Parkinson-White Syndrome, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress test (ECG)Diagnostic test
Every study participant undergoes a standard diagnostic stress ECG
| Study group | Role | What they receive |
|---|---|---|
| Stress ECG Test | Experimental | The whole study cohort undergoes the same diagnostic workup including stress test (ECG) Receives: Diagnostic Test: Stress test (ECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 test within a month
Secondary outcomes (3)
ERP-AP from invasive EPS
Effective Refractory Period of Accessory Pathways (ERP-AP) during programmed atrial pacing (ms)
Measured: 1 single measurement at aprox 1 month
SPERRI from invasive EPS
Shortest pre excited Interval between two cardiac cycles (SPERRI)
Measured: 1 single measurement at aprox 1 month
Anatomical localisation of the AP measured in the EPS
leftsided (superior, posterosuperior, posterior, posteroinferior, inferior) or rightsided (paraseptal, inferior, anteroinferior, anterior, anterosuperior and superior)
Measured: 1 single measurement at aprox 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start13 Apr 2017
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Why it stopped: The study aim was not relevant anymore because other studies became available recently on the same topic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wolff-Parkinson-White SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Balmer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Balmer, University Children's Hospital, Zurich
- Investigators
- Christian Balmer, PD Dr. med., Principal investigator, University Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207373
- Sponsor's protocol ID
- 2016-01943
- Other IDs
- 2016
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2017
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03207373
- Acronym / sponsor ID
- 2016-01943
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study aim was not relevant anymore because other studies became available recently on the same topic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Christian BalmerUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress ECG Test | Experimental | Diagnostic Test: Stress test (ECG)The whole study cohort undergoes the same diagnostic workup including stress test (ECG) |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress test (ECG)Every study participant undergoes a standard diagnostic stress ECG | Diagnostic test | Stress ECG Test |
Primary outcome
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)
3 secondary outcomes
ERP-AP from invasive EPS
Time frame: 1 single measurement at aprox 1 month
SPERRI from invasive EPS
Time frame: 1 single measurement at aprox 1 month
Anatomical localisation of the AP measured in the EPS
Time frame: 1 single measurement at aprox 1 month
Results and safety
The study was stopped early (reason given: The study aim was not relevant anymore because other studies became available recently on the same topic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Wolff-Parkinson-White Syndrome
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
RecruitingPhase 1/2
ATR 1072 in Participants With PRKAG2 Syndrome
Cardiac Glycogenosis, Cardiomyopathy
Not yet recruitingObservational study
Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
Atrioventricular Reentrant Tachycardias, Wolff-Parkinson-White (WPW) Syndrome
Active, not recruitingObservational study
Longitudinal Evaluation of Active-Duty Personnel with Accessory Pathways (LEAD-AP)
Cardiac Death, Cardiac Death, Sudden
RecruitingObservational study
Discrimination of Right Versus Left Septal Accessory Pathway Before and During the Electrophysiological Study
WPW Syndrome, Accessory Pathway
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Balmer, PD Dr. med. principal investigator
University Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress test (ECG) in people with Wolff-Parkinson-White Syndrome and Sudden Cardiac Death, run by Christian Balmer at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study aim was not relevant anymore because other studies became available recently on the same topic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycle length (CL) at the Stress ECG Test (time frame: 3 test within a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.