- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291544
Management of Supraventricular Tachycardias in Children
Management of Supraventricular Tachycardias in Children: A National Multicenter Study
Background
Supraventricular tachycardias (SVTs) are the most common arrhythmic events in children, with an estimated incidence of 13 per 100,000 per year before the age of 18. Few large patient cohorts have been reported, as most published studies are single-center. Large-scale studies come from medico-administrative databases, which lack the granularity needed for detailed analysis of outcomes according to the therapies used and the type of SVT.
Furthermore, although a large proportion of neonatal SVTs do not recur (spontaneous resolution of the accessory pathway), there are limited comparative data on the effectiveness of antiarrhythmic therapies specifically in children after the age of 1 year. Management therefore varies greatly, in part because current guidelines propose different therapeutic options based on low-level evidence.
Objectives:
- Describe the management of SVTs (antiarrhythmic therapies and catheter ablation) in children in France
- Compare the effectiveness of different antiarrhythmic treatments according to age (<1 year and >1 year) and type of SVT
- Analyze the incidence of adverse events and complications associated with antiarrhythmic treatments and catheter ablation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION
Supraventricular tachycardias (SVTs) represent the most frequent arrhythmic events in children, with an estimated incidence of 13 per 100,000 per year before the age of 18. This incidence is likely underestimated due to the often sporadic nature of symptoms and spontaneous resolution in a non-negligible proportion of patients.
Most SVTs in children are junctional tachycardias, particularly related to accessory pathways when symptoms begin before the age of 10. However, numerous different forms of SVT exist, with highly heterogeneous natural histories and prognoses. Few large patient cohorts have been reported, as most published studies are single-center. Larger-scale studies rely on medico-administrative databases, which lack sufficient granularity for a detailed analysis of outcomes based on the therapies implemented and the type of SVT.
Furthermore, although a large proportion of neonatal SVTs will not recur (due to spontaneous resolution of the accessory pathway), limited comparative data are available regarding the efficacy of antiarrhythmic therapies in children older than 1 year. Management is therefore highly variable, notably because current guidelines propose several therapeutic options supported by low-level evidence.
The aim of this study is to describe the epidemiology and management of SVTs in an unselected pediatric population across a broad network of centers in France, and to compare the efficacy of different therapies according to age and SVT type.
OBJECTIVES AND ENDPOINTS
Primary Objectives
- Describe the management (antiarrhythmic therapies and catheter ablation) of SVTs in children in France.
- Compare the efficacy of different antiarrhythmic treatments according to age (<1 year and >1 year) and SVT type.
- Assess the incidence of adverse events and complications associated with antiarrhythmic treatments and catheter ablation.
Primary Endpoints
- Proportion of antiarrhythmic therapies used by age group (<1 year and >1 year).
- Proportion of children referred for catheter ablation and age at ablation.
- Time between antiarrhythmic therapy initiation and first recurrence, according to treatment and age.
- Rate of adverse effects by antiarrhythmic treatment.
- Complications related to catheter ablation procedures.
METHODS
Study Design
National retrospective multicenter observational study from January 2000 to January 2024.
Study Population
All children <18 years old with a documented episode (ECG, Holter-ECG, wearable device, or implantable device) of sustained SVT (>30 seconds) will be eligible. Although most children in this context do not have structural heart disease, those with congenital or structural heart disease will also be eligible. Participation will be proposed to all pediatric cardiology centers in France through the Filiale de Cardiologie Pédiatrique et Congénitale (FCPC).
Inclusion Criteria
- Age <18 years at the time of the first documented SVT episode.
Exclusion Criteria
- Early postoperative SVT (<30 days).
- Age ≥18 years at the first documented SVT episode.
- Fetal tachycardias without postnatal recurrence.
- Atrial extrasystoles without sustained runs (<30 seconds).
Data Collection
Study data will be centralized, collected, and managed using REDCap electronic data capture tools hosted at Hôpital Européen Georges Pompidou. REDCap is a secure, web-based platform designed to support validated data entry, audit trails, automated exports to statistical software, and interoperability with external sources.
The list of collected variables is presented at the end of this document as a PDF of the electronic CRF.
Primary Endpoint
The primary endpoint will be SVT recurrence after at least five half-lives of the initiated antiarrhythmic therapy. Recurrence will be defined as any documented episode >30 seconds, or-if undocumented-an episode of palpitations or inappropriate tachycardia (for age and context) confirmed by medical personnel that results in hospitalization or a change in antiarrhythmic therapy.
Statistical Analyses
Data management and statistical analyses will be conducted by the statistical team at Hôpital Européen Georges Pompidou (Inserm U970, team 4). Categorical variables will be presented as counts and percentages. Continuous variables will be presented as mean ± SD or median (IQR), depending on distribution.
Comparisons will use χ² or Fisher's exact test for categorical variables and Student's t-test or Mann-Whitney-Wilcoxon test for continuous variables. Cox models will be used to identify factors associated with SVT recurrences and to compare treatment efficacy after verifying proportionality assumptions. Censoring will occur at loss to follow-up, heart transplantation, or death. Competing risk models (Fine and Gray) will be used to account for mortality. Recurrent event models and frailty models will also be used. Subgroup analyses will be performed based on underlying phenotype and SVT type. Kaplan-Meier survival curves will be generated. A two-sided P value <0.05 will be considered statistically significant. Analyses will be performed using R version 4.3.2.
ETHICS
Consent and Data Handling
Data will be anonymized using a unique study identifier. This is a retrospective observational study. Patient consent is not required under national human research regulations because:
- the project involves the use of existing records;
- data recorded by investigators will be free of patient identifiers;
- the study could not be feasibly conducted without a consent waiver, as it aims to include all eligible patients, including deceased individuals.
An information leaflet will however be available for patients, with the possibility to opt out.
Data Storage
Data will be hosted on a secure server at the Paris Cardiovascular Research Center (Inserm U970) through a REDCap electronic CRF. The server complies with the European General Data Protection Regulation. The computer used for analyses is located in a locked room within INSERM U970 with badge-restricted access.
No data will be transferred outside the research unit, as all analyses will be performed on-site. Data will be stored for 15 years after study completion in accordance with French biomedical research regulations, under the responsibility of Dr. V. Waldmann. Publications will contain no information that could directly or indirectly identify patients.
Data Access
Individuals authorized under applicable laws and regulations (e.g., investigators, quality control personnel, clinical research assistants, collaborators) must take all necessary precautions to ensure confidentiality of patient information.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age <18 years at the time of the first documented supraventricular tachycardia episode
Exclusion Criteria:
- Early postoperative supraventricular tachycardia (<30 days)
- Age ≥18 years at the first documented supraventricular tachycardia episode
- Fetal tachycardias without postnatal recurrence
- Atrial extrasystoles without sustained runs (<30 seconds)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antiarrhythmic therapies
Time Frame: At the time of the first supraventricular tachycardia recorded
|
Proportion of antiarrhythmic therapies used by age group (<1 year and >1 year)
|
At the time of the first supraventricular tachycardia recorded
|
|
Catheter ablation
Time Frame: At the time of first episode of supraventricular tachycardia or after recurrence
|
Proportion of children referred for catheter ablation and age at ablation
|
At the time of first episode of supraventricular tachycardia or after recurrence
|
|
Recurrence of supraventricular tachycardia
Time Frame: At 1 year after antiarrhythmic drug initiation
|
Time between antiarrhythmic therapy initiation and first recurrence, according to treatment and age
|
At 1 year after antiarrhythmic drug initiation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WALDMANN202501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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