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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Arrhythmia

Treatments: Other: questionnaire; Other: Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT06808204

69HCL24_0830

2024-A02568-39 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Children from 5 t17 years old suffering for arrythmia who need a transcatheter ablation

Experimental group

Treatment:

Other: Questionnaire