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Recruiting NCT06808204

NCT06808204 Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias

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Clinical Trial Summary
NCT ID NCT06808204
Status Recruiting
Phase
Sponsor Hospices Civils de Lyon
Condition Arrhythmia
Study Type OBSERVATIONAL
Enrollment 200 participants
Start Date 2025-09-23
Primary Completion 2027-03-23

Eligibility & Interventions

Sex All sexes
Min Age 5 Years
Max Age 17 Years
Study Type OBSERVATIONAL
Interventions
Peds QL 4.0 (Pediatric Quality of Life)Ricci and Gagnon questionnaireState and Trait Inventory

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 200 participants in total. It began in 2025-09-23 with a primary completion date of 2027-03-23.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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 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

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

Contact & Investigator

Central Contact

Francis BESSIERE, PU-PH

✉ francis.bessiere@chu-lyon.fr

📞 04 72 35 75 65

Principal Investigator

Francis BESSIERE, PU-PH

PRINCIPAL INVESTIGATOR

Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie

Frequently Asked Questions

Who can join the NCT06808204 clinical trial?

This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Arrhythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06808204 currently recruiting?

Yes, NCT06808204 is actively recruiting participants. Contact the research team at francis.bessiere@chu-lyon.fr for enrollment information.

Where is the NCT06808204 trial being conducted?

This trial is being conducted at Bron, France, Le Plessis-Robinson, France, Marseille, France, Paris, France and 3 additional locations.

Who is sponsoring the NCT06808204 clinical trial?

NCT06808204 is sponsored by Hospices Civils de Lyon. The principal investigator is Francis BESSIERE, PU-PH at Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie. The trial plans to enroll 200 participants.

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