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

Not Applicable

Not yet recruiting

• Conditions: Arrhythmia; Transcatheter Ablation

• Registration Number: NCT06808204
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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:

• 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Study Start: 2025-03-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients aged 8 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of life before and after transcatheter ablation	6 months after transcatheter ablation	Quality of life before and after transcatheter ablation according to Ped QL 4.0 questionnaire

Secondary Outcome Measures

Name	Time	Method
comparing level of activity before and after transcatheter ablation	6 months after transcatheter ablation	Level of activity before and after transcatheter ablation according to to the Ricci and Gagnon questionnaire
comparing level of anxiety before and after transcatheter ablation	6 months after transcatheter ablation	Level of anxiety before and after transcatheter ablation according to the State and Trait Anxiety Inventory questionnaire
comparing level of depression before and after transcatheter ablation	6 months after transcatheter ablation	Level of depression before and after transcatheter ablation according to the Child Depression Inventory questionnaire
Quality of life of parents before and after transcatheter ablation	6 months after transcatheter ablation	Quality of life before and after transcatheter ablation according to Ped QL 4.0 parents-kid questionnaire