Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
ConditionArrhythmia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorHospices Civils de Lyon
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Refusal of child or parents/legal guardians
Unability to understand and/or fill the quality of life questionnaire
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Peds QL 4.0 (Pediatric Quality of Life)
Other interventionQuality of life questionnaire
Ricci and Gagnon questionnaire
Other interventionPhysical activity level questionnaire
State and Trait Inventory
Other interventionAnxiety questionnaire
Child Depression Inventory
Other interventionDepression questionnaire
PEDS QL 4.0 parents-child
Other interventionFor parents before and after transcatheter ablation. Quality of life questionnaire.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation5 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
One day before transcatheter ablation2
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.
Time frame
3 months after transcatheter ablation3
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.
Time frame
6 months after transcatheter ablation4
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.
Time frame
12 months after transcatheter ablationSecondary outcomes
1
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).
Time frame
One day before transcatheter ablation2
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).
Time frame
3 months after transcatheter ablation3
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).
Time frame
6 months after transcatheter ablation4
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).
Time frame
12 months after transcatheter ablationSponsors and contacts
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Source ClinicalTrials.gov