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Recruiting NCT06808204

Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias

— Observational Arrhythmia

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peds QL 4.0 (Pediatric Quality of Life), Ricci and Gagnon questionnaire, State and Trait Inventory, Child Depression Inventory.
Who it may be relevant to
Registry conditions: Arrhythmia. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The goal of this clinical trial is to evaluate the improvement in the quality of life after the transcatheter ablation in children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation (according to PACES recommendations). The main question is how to evaluate an improvement in the quality of life in these children, according to different questionnaires? Participants will answer some questionnaires to get a global evaluation of the quality of life: * Peds QL 4.0 * Peds QL 4.0 by proxy, which will be completed by the parents * Ricci and Gagnon questionnaire * Child Depression Index * State and Trait Anxiety Inventory

Interventions

  • Other Peds QL 4.0 (Pediatric Quality of Life)
    Quality of life questionnaire
  • Other Ricci and Gagnon questionnaire
    Physical activity level questionnaire
  • Other State and Trait Inventory
    Anxiety questionnaire
  • Other Child Depression Inventory
    Depression questionnaire
  • Other PEDS QL 4.0 parents-child
    For parents before and after transcatheter ablation. Quality of life questionnaire.

Primary outcome measures

  • Quality of life before and after transcatheter ablation [Time frame: One day before transcatheter ablation]
  • Quality of life before and after transcatheter ablation [Time frame: 3 months after transcatheter ablation]
  • Quality of life before and after transcatheter ablation [Time frame: 6 months after transcatheter ablation]
  • Quality of life before and after transcatheter ablation [Time frame: 12 months after transcatheter ablation]
Secondary outcome measures (12)
  • Comparing level of activity before and after transcatheter ablation [Time frame: One day before transcatheter ablation]
  • Comparing level of activity before and after transcatheter ablation [Time frame: 3 months after transcatheter ablation]
  • Comparing level of activity before and after transcatheter ablation [Time frame: 6 months after transcatheter ablation]
  • Comparing level of activity before and after transcatheter ablation [Time frame: 12 months after transcatheter ablation]
  • Comparing level of anxiety before and after transcatheter ablation [Time frame: One day before transcatheter ablation]
  • Comparing level of anxiety before and after transcatheter ablation [Time frame: 3 months after transcatheter ablation]
  • Comparing level of anxiety before and after transcatheter ablation [Time frame: 6 months after transcatheter ablation]
  • Comparing level of anxiety before and after transcatheter ablation [Time frame: 12 months after transcatheter ablation]
  • Comparing level of depression before and after transcatheter ablation [Time frame: One day before transcatheter ablation]
  • Comparing level of depression before and after transcatheter ablation [Time frame: 3 months after transcatheter ablation]
  • Comparing level of depression before and after transcatheter ablation [Time frame: 6 months after transcatheter ablation]
  • Comparing level of depression before and after transcatheter ablation [Time frame: 12 months after transcatheter ablation]

Eligibility criteria

Inclusion criteria

  • Patients aged 5 to 17
  • Patients with a rhythm disorder,
  • Patients with indication for catheter ablation according to PACES (Pediatric and Congenital Electrophysiology Society) recommendations,
  • Patients and/or their parents/legal guardians who have given their non-objection to the study.

Exclusion criteria

  • Refusal of child or parents/legal guardians
  • Unability to understand and/or fill the quality of life questionnaire

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 7 centers
  • Hôpital cardiologique Louis Pradel — Bron
  • Hôpital Marie Lannelongue — Le Plessis-Robinson
  • Hôpital de la Timone — Marseille
  • Hôpital Necker Enfants Malades — Paris
  • Hôpital Cardiologique du Haut Lévêque - Service de cardiologie-électrophysiologie et stimu — Pessac
  • Hôpital Cardiologique du Haut Lévêque - Service des maladies cardio-vasculaires congénital — Pessac
  • Clinique Pasteur — Toulouse

Identifiers

NCT: NCT06808204 · 69HCL24_0830 · 2024-A02568-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗