Clinical trial NCT06808204: Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
Official title: Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrhythmia
Keywords: children
arrythmia
transcatheter ablation
quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility 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

Primary outcomes:
measure: Quality of life before and after transcatheter ablation
timeFrame: one day before transcatheter ablation
measure: Quality of life before and after transcatheter ablation
timeFrame: 3 months after transcatheter ablation
measure: Quality of life before and after transcatheter ablation
timeFrame: 6 months after transcatheter ablation
Secondary outcomes:
measure: comparing level of activity before and after transcatheter ablation
timeFrame: one day before transcatheter ablation
measure: comparing level of activity before and after transcatheter ablation
timeFrame: 3 months after transcatheter ablation
measure: comparing level of activity before and after transcatheter ablation
timeFrame: 6 months after transcatheter ablation
measure: comparing level of anxiety before and after transcatheter ablation
timeFrame: one day before transcatheter ablation
measure: comparing level of anxiety before and after transcatheter ablation
timeFrame: 3 months after transcatheter ablation
measure: comparing level of anxiety before and after transcatheter ablation
timeFrame: 6 months after transcatheter ablation
measure: comparing level of depression before and after transcatheter ablation
timeFrame: one day before transcatheter ablation
measure: comparing level of depression before and after transcatheter ablation
timeFrame: 3 months after transcatheter ablation
measure: comparing level of depression before and after transcatheter ablation
timeFrame: 6 months after transcatheter ablation
measure: Quality of life of parents before and after transcatheter ablation
timeFrame: one day before transcatheter ablation
measure: Quality of life of parents before and after transcatheter ablation
timeFrame: 3 months after transcatheter ablation
measure: Quality of life of parents before and after transcatheter ablation
timeFrame: 6 months after transcatheter ablation
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital cardiologique Louis Pradel
city: Le Plessis-Robinson
country: France
facility: Hôpital Marie Lannelongue
city: Marseille
country: France
facility: Hôpital de la Timone
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut Lévêque - Service de cardiologie-électrophysiologie et stimulation cardiaque
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut Lévêque - Service des maladies cardio-vasculaires congénitales
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie
name: Francis BESSIERE, Dr
role: PRINCIPAL_INVESTIGATOR
References: