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 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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

200

participants targeted

Target at P75+ for all trials

Timeline

9mo left

Started Sep 2025

Geographic Reach

1 country

7 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Progress49%

Sep 2025Mar 2027

First Submitted

Initial submission to the registry

January 29, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed

8 months until next milestone

Study Start

First participant enrolled

September 23, 2025

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

January 29, 2025

Last Update Submit

May 15, 2026

Conditions

Arrhythmia

Keywords

childrenarrythmiatranscatheter ablationquality of life

Outcome Measures

Primary Outcomes (4)

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.
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.
12 months after transcatheter ablation

Secondary Outcomes (16)

Comparing level of activity before and after transcatheter ablation
One day before transcatheter ablation
Comparing level of activity before and after transcatheter ablation
3 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation
6 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation
12 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
One day before transcatheter ablation
+11 more secondary outcomes

Study Arms (1)

Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation

Other: Peds QL 4.0 (Pediatric Quality of Life)Other: Ricci and Gagnon questionnaireOther: State and Trait InventoryOther: Child Depression InventoryOther: PEDS QL 4.0 parents-child