ArrhythmiaQUALICATRYTHMNCT06808204
Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
An observational study of Arrhythmia, run by Hospices Civils de Lyon at 7 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Peds QL 4.0 (Pediatric Quality of Life), Ricci and Gagnon questionnaire and State and Trait Inventory
- How many people
- 200 participants
- Where
- 7 sitesFrance
- Study dates
- 23 Sep 2025to 23 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- Refusal of child or parents/legal guardians
- Unability to understand and/or fill the quality of life questionnaire
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Hôpital cardiologique Louis Pradel
Bron, 69500
Francis BESSIERE, PU-PH, 04 72 35 75 65 ext. +33, francis.bessiere@chu-lyon.fr
Francis BESSIERE, PU-PH
- Recruiting
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
Alice MALTRET, M.D, 01 40 94 25 45 ext. +33, alice.maltret@gmail.com
Alice MALTRET, M.D.
- Recruiting
Hôpital de la Timone
Marseille, 13385
Linda KOUTBI, M.D., 04 91 38 65 75 ext. +33, Rita.KOUTBI@ap-hm.fr
Linda KOUTBI, M.D.
- Not yet recruiting
Hôpital Necker Enfants Malades
Paris, 75015
Victor WALDMANN, M.D., 01 44 49 43 44 ext. +33, victor.waldmann@aphp.fr
Victor WALDMANN, M.D.
- Not yet recruiting
Hôpital Cardiologique du Haut Lévêque - Service de cardiologie-électrophysiologie et stimulation cardiaque
Pessac, 33604
Nicolas DERVAL, M.D., nicolas.derval@chu-bordeaux.fr
Nicolas DERVAL, M.D.
- Not yet recruiting
Hôpital Cardiologique du Haut Lévêque - Service des maladies cardio-vasculaires congénitales
Pessac, 33604
Marion AUDIE, M.D., marion.audie@chu-bordeaux.fr
Marion AUDIE, M.D.
- Recruiting
Clinique Pasteur
Toulouse, 31076
Nicolas COMBES, M.D., 05 62 21 16 45 ext. +33, ncombes@clinique-pasteur.com
Nicolas COMBES, M.D.
About this study
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
- Conditions
- Arrhythmia
- Being tested
- Peds QL 4.0 (Pediatric Quality of Life), Ricci and Gagnon questionnaire, State and Trait Inventory, Child Depression Inventory, PEDS QL 4.0 parents-child
- Keywords
- children, arrythmia, transcatheter ablation, quality of life
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peds QL 4.0 (Pediatric Quality of Life)Other
Quality of life questionnaire
Ricci and Gagnon questionnaireOther
Physical activity level questionnaire
State and Trait InventoryOther
Anxiety questionnaire
Child Depression InventoryOther
Depression questionnaire
PEDS QL 4.0 parents-childOther
For parents before and after transcatheter ablation. Quality of life questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after transcatheter ablation
Secondary outcomes (16)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 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.
Measured: 12 months after transcatheter ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start23 Sep 2025
- Primary completion23 Sep 2029 (estimated)
- Study completion23 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis BESSIERE, PU-PH, Principal investigator, Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808204
- Sponsor's protocol ID
- 69HCL24_0830
- Other IDs
- 2024-A02568-39
- Acronym
- QUALICATRYTHM
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
- ClinicalTrials.gov ID
- NCT06808204
- Acronym / sponsor ID
- QUALICATRYTHM / 69HCL24_0830
- Conditions
- Arrhythmia
- Keywords
- children, arrythmia, transcatheter ablation, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 23 Sep 2029 (estimated)
- Study completion
- 23 Sep 2029 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 questionnaire, Other: State and Trait Inventory, Other: Child Depression Inventory, Other: PEDS QL 4.0 parents-child |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal of child or parents/legal guardians
- Unability to understand and/or fill the quality of life questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peds QL 4.0 (Pediatric Quality of Life)Quality of life questionnaire | Other | Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation |
| Ricci and Gagnon questionnairePhysical activity level questionnaire | Other | Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation |
| State and Trait InventoryAnxiety questionnaire | Other | Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation |
| Child Depression InventoryDepression questionnaire | Other | Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation |
| PEDS QL 4.0 parents-childFor parents before and after transcatheter ablation. Quality of life questionnaire. | Other | Children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation |
Primary outcome
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.
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.
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.
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.
16 secondary outcomes
Comparing level of activity before and after transcatheter ablation
Time frame: One day before transcatheter ablation
Comparing level of activity before and after transcatheter ablation
Time frame: 3 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation
Time frame: 6 months after transcatheter ablation
Comparing level of activity before and after transcatheter ablation
Time frame: 12 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
Time frame: One day before transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
Time frame: 3 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
Time frame: 6 months after transcatheter ablation
Comparing level of anxiety before and after transcatheter ablation
Time frame: 12 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation
Time frame: One day before transcatheter ablation
Comparing level of depression before and after transcatheter ablation
Time frame: 3 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation
Time frame: 6 months after transcatheter ablation
Comparing level of depression before and after transcatheter ablation
Time frame: 12 months after transcatheter ablation
Quality of life of parents before and after transcatheter ablation
Time frame: One day before transcatheter ablation
Quality of life of parents before and after transcatheter ablation
Time frame: 3 months after transcatheter ablation
Quality of life of parents before and after transcatheter ablation
Time frame: 6 months after transcatheter ablation
Quality of life of parents before and after transcatheter ablation
Time frame: 12 months after transcatheter ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis BESSIERE, PU-PH principal investigator
Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia, run by Hospices Civils de Lyon at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francis BESSIERE, PU-PH (04 72 35 75 65 ext. +33, francis.bessiere@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life before and after transcatheter ablation (time frame: One day before transcatheter ablation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.