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NCT Number: NCT06808204

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

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

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital cardiologique Louis Pradel, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peds QL 4.0 (Pediatric Quality of Life)

Other

Quality of life questionnaire

Ricci and Gagnon questionnaire

Other

Physical activity level questionnaire

State and Trait Inventory

Other

Anxiety questionnaire

Child Depression Inventory

Other

Depression questionnaire

PEDS QL 4.0 parents-child

Other

For parents before and after transcatheter ablation. Quality of life questionnaire.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Quality of life before and after transcatheter ablation

    Time frame: 12 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

  1. Comparing level of activity before and after transcatheter ablation

    Time frame: One day before 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).

  2. Comparing level of activity before and after transcatheter ablation

    Time frame: 3 months 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. Comparing level of activity before and after transcatheter ablation

    Time frame: 6 months 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).

  4. Comparing level of activity before and after transcatheter ablation

    Time frame: 12 months 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).

  5. Comparing level of anxiety before and after transcatheter ablation

    Time frame: One day before 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. Comparing level of anxiety before and after transcatheter ablation

    Time frame: 3 months 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.

  7. Comparing level of anxiety before and after transcatheter ablation

    Time frame: 6 months 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.

  8. Comparing level of anxiety before and after transcatheter ablation

    Time frame: 12 months 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.

  9. Comparing level of depression before and after transcatheter ablation

    Time frame: One day before 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.

  10. Comparing level of depression before and after transcatheter ablation

    Time frame: 3 months 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.

  11. Comparing level of depression before and after transcatheter ablation

    Time frame: 6 months 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. Comparing level of depression before and after transcatheter ablation

    Time frame: 12 months 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.

  13. Quality of life of parents before and after transcatheter ablation

    Time frame: One day before 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.

  14. Quality of life of parents before and after transcatheter ablation

    Time frame: 3 months 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.

  15. Quality of life of parents before and after transcatheter ablation

    Time frame: 6 months 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.

  16. Quality of life of parents before and after transcatheter ablation

    Time frame: 12 months 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francis BESSIERE, PU-PH

CONTACT

[email protected]

04 72 35 75 65 ext. +33

Nawel BABOURI

CONTACT

[email protected]

04 26 73 93 83 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: QUALICATRYTHM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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