--- title: Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias nct_id: NCT06808204 overall_status: RECRUITING phase: NA sponsor: Hospices Civils de Lyon study_type: INTERVENTIONAL primary_condition: Arrhythmia countries: France canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06808204.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06808204" ct_last_update_post_date: 2026-05-11 last_seen_at: "2026-05-12T06:40:56.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias **NCT ID:** [NCT06808204](https://clinicaltrials.gov/study/NCT06808204) ## Key Facts - **Status:** RECRUITING - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 200 - **Lead Sponsor:** Hospices Civils de Lyon - **Conditions:** Arrhythmia - **Start Date:** 2025-09-23 - **Completion Date:** 2027-03-23 - **CT.gov Last Update:** 2026-05-11 ## 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 - **Minimum age:** 5 Years - **Maximum age:** 17 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation** (EXPERIMENTAL) ## Interventions - **Questionnaire** (OTHER) — Quality of life questionnaire : Peds QL 4.0 (Pediatric Quality of Life ) - **questionnaire** (OTHER) — Physical activity level : Ricci and Gagnon questionnaire - **questionnaire** (OTHER) — Anxiety questionnaire : State and Trait Inventory - **questionnaire** (OTHER) — Depression questionnaire : Child Depression Inventory - **questionnaire** (OTHER) — Child Depression Inventory - **questionnaire** (OTHER) — Quality of life of parents before and after transcatheter ablation ## Primary Outcomes - **Quality of life before and after transcatheter ablation** _(time frame: one day before transcatheter ablation)_ — Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire. The questionnaire consists of 23 questions covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is used for the young child self-report (ages 5 to 7) (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate a better assessment of health-related quality of life. - **Quality of life before and after transcatheter ablation** _(time frame: 3 months after transcatheter ablation)_ — Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire. The questionnaire consists of 23 questions covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is used for the young child self-report (ages 5 to 7) (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate a better assessment of health-related quality of life. - **Quality of life before and after transcatheter ablation** _(time frame: 6 months after transcatheter ablation)_ — Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire. The questionnaire consists of 23 questions covering 4 different areas: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). A 5-point response scale is used across the child self-report (for ages 8 to 18) and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). A 3-point scale is used for the young child self-report (ages 5 to 7) (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3= 25, 4 = 0), so that higher scores indicate a better assessment of health-related quality of life. ## Secondary Outcomes - **comparing level of activity before and after transcatheter ablation** _(time frame: one day before transcatheter ablation)_ - **comparing level of activity before and after transcatheter ablation** _(time frame: 3 months after transcatheter ablation)_ - **comparing level of activity before and after transcatheter ablation** _(time frame: 6 months after transcatheter ablation)_ - **comparing level of anxiety before and after transcatheter ablation** _(time frame: one day before transcatheter ablation)_ - **comparing level of anxiety before and after transcatheter ablation** _(time frame: 3 months after transcatheter ablation)_ - **comparing level of anxiety before and after transcatheter ablation** _(time frame: 6 months after transcatheter ablation)_ - **comparing level of depression before and after transcatheter ablation** _(time frame: one day before transcatheter ablation)_ - **comparing level of depression before and after transcatheter ablation** _(time frame: 3 months after transcatheter ablation)_ - **comparing level of depression before and after transcatheter ablation** _(time frame: 6 months after transcatheter ablation)_ - **Quality of life of parents before and after transcatheter ablation** _(time frame: one day before transcatheter ablation)_ - **Quality of life of parents before and after transcatheter ablation** _(time frame: 3 months after transcatheter ablation)_ - **Quality of life of parents before and after transcatheter ablation** _(time frame: 6 months after transcatheter ablation)_ ## Locations (7) - 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_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hôpital cardiologique louis pradel|bron||france` — added _(2026-05-12)_ - `locations.hôpital marie lannelongue|le plessis-robinson||france` — added _(2026-05-12)_ - `locations.hôpital de la timone|marseille||france` — added _(2026-05-12)_ - `locations.hôpital necker enfants malades|paris||france` — added _(2026-05-12)_ - `locations.hôpital cardiologique du haut lévêque - service de cardiologie-électrophysiologie et stimulation cardiaque|pessac||france` — added _(2026-05-12)_ - `locations.hôpital cardiologique du haut lévêque - service des maladies cardio-vasculaires congénitales|pessac||france` — added _(2026-05-12)_ - `locations.clinique pasteur|toulouse||france` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06808204.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06808204* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*