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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-02-01

Brief Summary

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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

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Detailed Description

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Conditions

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Arrhythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Questionnaire

Intervention Type OTHER

Quality of life questionnaire : Peds QL 4.0 (Pediatric Quality of Life )

questionnaire

Intervention Type OTHER

Physical activity level : Ricci and Gagnon questionnaire

questionnaire

Intervention Type OTHER

Anxiety questionnaire : State and Trait Inventory

questionnaire

Intervention Type OTHER

Depression questionnaire : Child Depression Inventory

questionnaire

Intervention Type OTHER

Child Depression Inventory

questionnaire

Intervention Type OTHER

Quality of life of parents before and after transcatheter ablation

Interventions

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Questionnaire

Quality of life questionnaire : Peds QL 4.0 (Pediatric Quality of Life )

Intervention Type OTHER

questionnaire

Physical activity level : Ricci and Gagnon questionnaire

Intervention Type OTHER

questionnaire

Anxiety questionnaire : State and Trait Inventory

Intervention Type OTHER

questionnaire

Depression questionnaire : Child Depression Inventory

Intervention Type OTHER

questionnaire

Child Depression Inventory

Intervention Type OTHER

questionnaire

Quality of life of parents before and after transcatheter ablation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis BESSIERE, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie

Locations

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Hôpital cardiologique Louis Pradel

Bron, , France

Site Status RECRUITING