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

Study acronym: QUALICATRYTHM
StatusRecruiting
PhaseNot specified
Started2025-09-23
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 months later Mar 23, 2027 → Sep 23, 2029
See other at-risk trials from Hospices Civils de Lyon

Amendment history

2026-09-29
Primary completion pushed: 2027-03-23 → 2029-09-23
Completion pushed: 2027-03-23 → 2029-09-23
2026-05-15
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Phase changed: not applicable → not specified
Primary endpoint(s) modified3 to 4 entries
WasQuality of life before and after transcatheter ablation, Quality of life before and after transcatheter ablation, Quality of life before and after transcatheter ablation
NowQuality of life before and after transcatheter ablation, Quality of life before and after transcatheter ablation, Quality of life before and after transcatheter ablation, Quality of life before and after transcatheter ablation
InterventionsQuestionnaire (Other), questionnaire (Other), questionnaire (Other), questionnaire (Other), questionnaire (Other), questionnaire (Other)→Child Depression Inventory (Other), PEDS QL 4.0 parents-child (Other), Peds QL 4.0 (Pediatric Quality of Life) (Other), Ricci and Gagnon…
Eligibility criteriarevised
Inclusion Criteria: Patients aged 85 to 17 Patients with a rhythm disorder, Patients with indica [...]
Secondary endpoints12 to 16 entries
comparingComparing level of activity before and after transcatheter ablation comparingComparing level of activity before and after transcatheter ablation comparingComparing level of activity before and after transcatheter ablation comparingComparing level of activity before and after transcatheter ablation Comparing level of anxiety before and after transcatheter ablation comparingComparing level of anxiety before and after transcatheter ablation comparingComparing level of anxiety before and after transcatheter ablation comparingComparing level of anxiety before and after transcatheter ablati [...] [...]
Study sitesdetails revised at 6 of 7 sites
2026-05-07
Study Status, Arms and Interventions, Contacts/Locations v2
Primary completion date2027-02-01→2027-03-23
Completion date2027-02-01→2027-03-23
Start dateestimated 2025-08-01→confirmed 2025-09-23
Study sitescontacts updated at 1 of 7 sites
2025-06-12
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Conditions, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-09-01→2027-02-01
Completion date2026-09-01→2027-02-01
Start date2025-03-01→2025-08-01
Study sites0→7
Secondary endpointsdetails revised at 12 of 12 entries
Study titlerevised
Quality of Life Before and After Transcatheter Ablation in Children withWith Arrythmias
2025-01-29
Original filing
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
Trial Details
NCT Number NCT06808204
Lead Sponsor Hospices Civils de Lyon
Conditions Arrhythmia
Enrollment 200 participants
Start Date 2025-09-23
Primary Completion 2029-09-23 (estimated)
Study Completion 2029-09-23 (estimated)
Updated on ClinicalTrials.gov 2026-09-28