Children's quality of life before and after catheter ablation for arrhythmia
Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
This will see if catheter ablation improves quality of life in children aged 8–17 who need the procedure for arrhythmia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 7 sites (Bron and 6 other locations) |
| Trial ID | NCT06808204 on ClinicalTrials.gov |
What this trial studies
Children aged 8 to 17 who are recommended for catheter (transcatheter) ablation will complete standardized questionnaires before the procedure and at follow-up to measure changes in quality of life, mood, and anxiety. Questionnaires include the PedsQL 4.0 (child and parent proxy), the Ricci and Gagnon questionnaire, the Child Depression Inventory, and the State-Trait Anxiety Inventory. Parents will complete proxy versions where appropriate and all data will be compared pre- and post-ablation to quantify change. Enrollment follows PACES indications for pediatric ablation and excludes those unable to understand or complete the questionnaires.
Who should consider this trial
Good fit: Children aged 8–17 with a rhythm disorder who have an indication for catheter ablation according to PACES recommendations and whose child and/or parents consent to complete questionnaires are ideal candidates.
Not a fit: Children outside the 8–17 age range, those without an indication for ablation, or those unable to understand or complete the questionnaires are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, the results could show that catheter ablation leads to measurable improvements in daily functioning, emotional well-being, and anxiety levels for children with arrhythmia.
How similar studies have performed: Previous pediatric studies have shown that catheter ablation reduces arrhythmia burden and can improve quality of life, but comprehensive pre/post assessments using multiple validated questionnaires remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bron and 6 other locations
- Hôpital cardiologique Louis Pradel — Bron, France (Recruiting)
- Hôpital Marie Lannelongue — Le Plessis-Robinson, France (Not_yet_recruiting)
- Hôpital de la Timone — Marseille, France (Not_yet_recruiting)
- Hôpital Necker Enfants Malades — Paris, France (Not_yet_recruiting)
- Hôpital Cardiologique du Haut Lévêque - Service de cardiologie-électrophysiologie et stimulation cardiaque — Pessac, France (Not_yet_recruiting)
- Hôpital Cardiologique du Haut Lévêque - Service des maladies cardio-vasculaires congénitales — Pessac, France (Not_yet_recruiting)
- Clinique Pasteur — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Francis BESSIERE, Dr — Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie
- Study coordinator: Francis BESSIERE, Dr
- Email: francis.bessiere@chu-lyon.fr
- Phone: 04 72 35 75 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.