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

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

Study Overview

• Status: Recruiting
• Conditions: Arrhythmia
• Intervention / Treatment: Other: Peds QL 4.0 (Pediatric Quality of Life); Other: Ricci and Gagnon questionnaire; Other: State and Trait Inventory; Other: Child Depression Inventory; Other: PEDS QL 4.0 parents-child

• Study Type: Observational
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francis BESSIERE, PU-PH; Phone Number: +33 04 72 35 75 65; Email: francis.bessiere@chu-lyon.fr
• Study Contact Backup: Name: Nawel BABOURI; Phone Number: +33 04 26 73 93 83; Email: nawel.babouri@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hôpital cardiologique Louis Pradel
    • Contact: Francis BESSIERE, PU-PH; Phone Number: +33 04 72 35 75 65; Email: francis.bessiere@chu-lyon.fr
    • Principal Investigator: Francis BESSIERE, PU-PH
  • Le Plessis-Robinson, France, 92350
    • Recruiting
    • Hôpital Marie Lannelongue
    • Contact: Alice MALTRET, M.D; Phone Number: +33 01 40 94 25 45; Email: alice.maltret@gmail.com
    • Principal Investigator: Alice MALTRET, M.D.
  • Marseille, France, 13385
    • Recruiting
    • Hopital de la Timone
    • Contact: Linda KOUTBI, M.D.; Phone Number: +33 04 91 38 65 75; Email: Rita.KOUTBI@ap-hm.fr
    • Principal Investigator: Linda KOUTBI, M.D.
  • Paris, France, 75015
    • Not yet recruiting
    • Hôpital Necker Enfants Malades
    • Contact: Victor WALDMANN, M.D.; Phone Number: +33 01 44 49 43 44; Email: victor.waldmann@aphp.fr
    • Principal Investigator: Victor WALDMANN, M.D.
  • Pessac, France, 33604
    • Not yet recruiting
    • Hôpital Cardiologique du Haut Lévêque - Service de cardiologie-électrophysiologie et stimulation cardiaque
    • Contact: Nicolas DERVAL, M.D.; Email: nicolas.derval@chu-bordeaux.fr
    • Principal Investigator: Nicolas DERVAL, M.D.
  • Pessac, France, 33604
    • Not yet recruiting
    • Hôpital Cardiologique du Haut Lévêque - Service des maladies cardio-vasculaires congénitales
    • Contact: Marion AUDIE, M.D.; Email: marion.audie@chu-bordeaux.fr
    • Principal Investigator: Marion AUDIE, M.D.
  • Toulouse, France, 31076
    • Recruiting
    • Clinique Pasteur
    • Contact: Nicolas COMBES, M.D.; Phone Number: +33 05 62 21 16 45; Email: ncombes@clinique-pasteur.com
    • Principal Investigator: Nicolas COMBES, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children from 5 to 17 years old suffering from arrythmias with transcathter ablation needed according to PACES recommendation, with medical care in one of the following center :

• Lyon - HCL - Hôpital cardiologique Louis Pradel
• Paris - AP HP - Necker enfant malades
• Plessis Robinson - Hôpital Marie Lannelongue
• Bordeaux - CHU Bordeaux - Haut Lévesque - Pessac
• Toulouse - Clinique Pasteur
• Marseille - AP HM - La Timone

Description

Inclusion Criteria:

• Patients aged 5 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation	Other: Peds QL 4.0 (Pediatric Quality of Life); Quality of life questionnaire; Other: Ricci and Gagnon questionnaire; Physical activity level questionnaire; Other: State and Trait Inventory; Anxiety questionnaire; Other: Child Depression Inventory; Depression questionnaire; Other: PEDS QL 4.0 parents-child; For parents before and after transcatheter ablation. Quality of life questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life before and 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.	3 months after transcatheter ablation
Quality of life before and 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.	6 months after transcatheter ablation
Quality of life before and 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.	One day before transcatheter ablation
Quality of life before and 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.	12 months after transcatheter ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of parents before and after transcatheter ablation	Quality of life before and after transcatheter ablation according to PedsQL version 4.0 parents-kid 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.	3 months after transcatheter ablation
Quality of life of parents before and after transcatheter ablation	Quality of life before and after transcatheter ablation according to PedsQL version 4.0 parents-kid 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.	6 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation	Level of activity before and after transcatheter ablation according to to the Ricci and Gagnon questionnaire. The self-assessment questionnaire is used to determine the patient's activity profile: inactive, active or very active. It consists of 9 questions with 5 suggested answers (giving a score from 1 to 5 for each answer given). The higher the score, the more active the profile (Less than 18 points in total: Inactive, Between 18 and 35 points in total: Active, More than 35 points in total: Very active).	One day before transcatheter ablation
Comparing level of activity before and after transcatheter ablation	Level of activity before and after transcatheter ablation according to to the Ricci and Gagnon questionnaire The self-assessment questionnaire is used to determine the patient's activity profile: inactive, active or very active. It consists of 9 questions with 5 suggested answers (giving a score from 1 to 5 for each answer given). The higher the score, the more active the profile (Less than 18 points in total: Inactive, Between 18 and 35 points in total: Active, More than 35 points in total: Very active).	3 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation	Level of activity before and after transcatheter ablation according to to the Ricci and Gagnon questionnaire The self-assessment questionnaire is used to determine the patient's activity profile: inactive, active or very active. It consists of 9 questions with 5 suggested answers (giving a score from 1 to 5 for each answer given). The higher the score, the more active the profile (Less than 18 points in total: Inactive, Between 18 and 35 points in total: Active, More than 35 points in total: Very active).	6 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation	Level of activity before and after transcatheter ablation according to to the Ricci and Gagnon questionnaire. The self-assessment questionnaire is used to determine the patient's activity profile: inactive, active or very active. It consists of 9 questions with 5 suggested answers (giving a score from 1 to 5 for each answer given). The higher the score, the more active the profile (Less than 18 points in total: Inactive, Between 18 and 35 points in total: Active, More than 35 points in total: Very active).	12 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation	Level of anxiety before and after transcatheter ablation according to the State-Trait Anxiety Inventory for Children (STAIC) questionnaire. The STAIC comprises 2 series of 20 items each: one concerns anxiety as a 'personality trait'; the other series concerns the subject's 'state of anxiety' at the time of completing the questionnaire, which may fluctuate over time. Each item is rated on a scale of 1 to 3. The overall score is obtained by a simple sum. The overall score varies between 20 and 60. The threshold score defining pathological anxiety is 34. The higher the score, the more anxious the patient.	One day before transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation	Level of anxiety before and after transcatheter ablation according to the State-Trait Anxiety Inventory for Children (STAIC) questionnaire. The STAIC comprises 2 series of 20 items each: one concerns anxiety as a 'personality trait'; the other series concerns the subject's 'state of anxiety' at the time of completing the questionnaire, which may fluctuate over time. Each item is rated on a scale of 1 to 3. The overall score is obtained by a simple sum. The overall score varies between 20 and 60. The threshold score defining pathological anxiety is 34. The higher the score, the more anxious the patient.	3 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation	Level of anxiety before and after transcatheter ablation according to the State-Trait Anxiety Inventory for Children (STAIC) questionnaire. The STAIC comprises 2 series of 20 items each: one concerns anxiety as a 'personality trait'; the other series concerns the subject's 'state of anxiety' at the time of completing the questionnaire, which may fluctuate over time. Each item is rated on a scale of 1 to 3. The overall score is obtained by a simple sum. The overall score varies between 20 and 60. The threshold score defining pathological anxiety is 34. The higher the score, the more anxious the patient.	6 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation	Level of anxiety before and after transcatheter ablation according to the State-Trait Anxiety Inventory for Children (STAIC) questionnaire. The STAIC comprises 2 series of 20 items each: one concerns anxiety as a 'personality trait'; the other series concerns the subject's 'state of anxiety' at the time of completing the questionnaire, which may fluctuate over time. Each item is rated on a scale of 1 to 3. The overall score is obtained by a simple sum. The overall score varies between 20 and 60. The threshold score defining pathological anxiety is 34. The higher the score, the more anxious the patient.	12 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation	Level of depression before and after transcatheter ablation according to the Child Depression Inventory (CDI) questionnaire. This questionnaire measures the intensity of depression in children and adolescents aged 7 to 17. Each item is scored from 0 (normal behaviour for age or absent) to 2 (severe). Adding the items together gives a total score of between 0 and 54. The higher the score, the more pathological the condition.	One day before transcatheter ablation
Comparing level of depression before and after transcatheter ablation	Level of depression before and after transcatheter ablation according to the Child Depression Inventory (CDI) questionnaire. This questionnaire measures the intensity of depression in children and adolescents aged 7 to 17. Each item is scored from 0 (normal behaviour for age or absent) to 2 (severe). Adding the items together gives a total score of between 0 and 54. The higher the score, the more pathological the condition.	3 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation	Level of depression before and after transcatheter ablation according to the Child Depression Inventory (CDI) questionnaire. This questionnaire measures the intensity of depression in children and adolescents aged 7 to 17. Each item is scored from 0 (normal behaviour for age or absent) to 2 (severe). Adding the items together gives a total score of between 0 and 54. The higher the score, the more pathological the condition.	6 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation	Level of depression before and after transcatheter ablation according to the Child Depression Inventory (CDI) questionnaire. This questionnaire measures the intensity of depression in children and adolescents aged 7 to 17. Each item is scored from 0 (normal behaviour for age or absent) to 2 (severe). Adding the items together gives a total score of between 0 and 54. The higher the score, the more pathological the condition.	12 months after transcatheter ablation
Quality of life of parents before and after transcatheter ablation	Quality of life before and after transcatheter ablation according to PedsQL version 4.0 parents-kid 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.	One day before transcatheter ablation
Quality of life of parents before and after transcatheter ablation	Quality of life before and after transcatheter ablation according to PedsQL version 4.0 parents-kid 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.	12 months after transcatheter ablation

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Francis BESSIERE, PU-PH, Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2025
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): March 23, 2027

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; children; arrythmia; transcatheter ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 69HCL24_0830; 2024-A02568-39 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No