Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT06808204
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life before and after transcatheter ablation', 'timeFrame': 'one day before transcatheter ablation', 'description': 'Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire.\n\nThe 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).\n\nA 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).\n\nItems 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.'}, {'measure': 'Quality of life before and after transcatheter ablation', 'timeFrame': '3 months after transcatheter ablation', 'description': 'Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire.\n\nThe 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).\n\nA 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).\n\nItems 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.'}, {'measure': 'Quality of life before and after transcatheter ablation', 'timeFrame': '6 months after transcatheter ablation', 'description': 'Quality of life before and after transcatheter ablation according to Quality of Life Inventory paediatrics (PedsQL) version 4.0 questionnaire.\n\nThe 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).\n\nA 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).\n\nItems 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.'}], 'secondaryOutcomes': [{'measure': 'comparing level of activity before and after transcatheter ablation', 'timeFrame': 'one day before transcatheter ablation', 'description': "Level of activity before and after transcatheter ablation according to to the Ricci and Gagnon questionnaire.\n\nThe 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).\n\nThe 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)."}, {'measure': 'comparing level of activity before and after transcatheter ablation', 'timeFrame': '3 months after transcatheter ablation', 'description': "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).\n\nThe 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)."}, {'measure': 'comparing level of activity before and after transcatheter ablation', 'timeFrame': '6 months after transcatheter ablation', 'description': "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).\n\nThe 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)."}, {'measure': 'comparing level of anxiety before and after transcatheter ablation', 'timeFrame': 'one day before transcatheter ablation', 'description': "Level of anxiety before and after transcatheter ablation according to the State-Trait Anxiety Inventory for Children (STAIC) questionnaire.\n\nThe 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.\n\nEach 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."}, {'measure': 'comparing level of anxiety before and after transcatheter ablation', 'timeFrame': '3 months after transcatheter ablation', 'description': "Level of anxiety before and after transcatheter ablation according to the State-Trait Anxiety Inventory for Children (STAIC) questionnaire.\n\nThe 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.\n\nEach 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."}, {'measure': 'comparing level of anxiety before and after transcatheter ablation', 'timeFrame': '6 months after transcatheter ablation', 'description': "Level of anxiety before and after transcatheter ablation according to the State-Trait Anxiety Inventory for Children (STAIC) questionnaire.\n\nThe 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.\n\nEach 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."}, {'measure': 'comparing level of depression before and after transcatheter ablation', 'timeFrame': 'one day before transcatheter ablation', 'description': 'Level of depression before and after transcatheter ablation according to the Child Depression Inventory (CDI) questionnaire.\n\nThis questionnaire measures the intensity of depression in children and adolescents aged 7 to 17.\n\nEach 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.'}, {'measure': 'comparing level of depression before and after transcatheter ablation', 'timeFrame': '3 months after transcatheter ablation', 'description': 'Level of depression before and after transcatheter ablation according to the Child Depression Inventory (CDI) questionnaire.\n\nThis questionnaire measures the intensity of depression in children and adolescents aged 7 to 17.\n\nEach 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.'}, {'measure': 'comparing level of depression before and after transcatheter ablation', 'timeFrame': '6 months after transcatheter ablation', 'description': 'Level of depression before and after transcatheter ablation according to the Child Depression Inventory (CDI) questionnaire.\n\nThis questionnaire measures the intensity of depression in children and adolescents aged 7 to 17.\n\nEach 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.'}, {'measure': 'Quality of life of parents before and after transcatheter ablation', 'timeFrame': 'one day before transcatheter ablation', 'description': 'Quality of life before and after transcatheter ablation according to PedsQL version 4.0 parents-kid questionnaire\n\nThe 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).\n\nA 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).\n\nItems 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.'}, {'measure': 'Quality of life of parents before and after transcatheter ablation', 'timeFrame': '3 months after transcatheter ablation', 'description': 'Quality of life before and after transcatheter ablation according to PedsQL version 4.0 parents-kid questionnaire\n\nThe 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).\n\nA 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).\n\nItems 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.'}, {'measure': 'Quality of life of parents before and after transcatheter ablation', 'timeFrame': '6 months after transcatheter ablation', 'description': 'Quality of life before and after transcatheter ablation according to PedsQL version 4.0 parents-kid questionnaire\n\nThe 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).\n\nA 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).\n\nItems 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children', 'arrythmia', 'transcatheter ablation', 'quality of life'], 'conditions': ['Arrhythmia']}, 'descriptionModule': {'briefSummary': '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:\n\n• to evaluate an improvement in the quality of life in these children, according to different questionnaires?\n\nParticipants will answer some questionnaires to get a global evaluation of the quality of life:\n\n* Peds QL 4.0\n* Peds QL 4.0 by proxy, which will be completed by the parents\n* Ricci and Gagnon questionnaire\n* Child Depression Index\n* State and Trait Anxiety Inventory'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 8 to 17\n* Patients with a rhythm disorder,\n* Patients with indication for catheter ablation according to PACES (Pediatric and Congenital Electrophysiology Society) recommendations,\n* Patients and/or their parents/legal guardians who have given their non-objection to the study.\n\nExclusion Criteria:\n\n* Refusal of child or parents/legal guardians\n* Unability to understand and/or fill the quality of life questionnaire'}, 'identificationModule': {'nctId': 'NCT06808204', 'acronym': 'QUALICATRYTHM', 'briefTitle': 'Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias', 'orgStudyIdInfo': {'id': '69HCL24_0830'}, 'secondaryIdInfos': [{'id': '2024-A02568-39', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children from 5 t17 years old suffering for arrythmia who need a transcatheter ablation', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Quality of life questionnaire : Peds QL 4.0 (Pediatric Quality of Life )', 'armGroupLabels': ['Children from 5 t17 years old suffering for arrythmia who need a transcatheter ablation']}, {'name': 'questionnaire', 'type': 'OTHER', 'description': 'Physical activity level : Ricci and Gagnon questionnaire', 'armGroupLabels': ['Children from 5 t17 years old suffering for arrythmia who need a transcatheter ablation']}, {'name': 'questionnaire', 'type': 'OTHER', 'description': 'Anxiety questionnaire : State and Trait Inventory', 'armGroupLabels': ['Children from 5 t17 years old suffering for arrythmia who need a transcatheter ablation']}, {'name': 'questionnaire', 'type': 'OTHER', 'description': 'Depression questionnaire : Child Depression Inventory', 'armGroupLabels': ['Children from 5 t17 years old suffering for arrythmia who need a transcatheter ablation']}, {'name': 'questionnaire', 'type': 'OTHER', 'description': 'Child Depression Inventory', 'armGroupLabels': ['Children from 5 t17 years old suffering for arrythmia who need a transcatheter ablation']}, {'name': 'questionnaire', 'type': 'OTHER', 'description': 'Quality of life of parents before and after transcatheter ablation', 'armGroupLabels': ['Children from 5 t17 years old suffering for arrythmia who need a transcatheter ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francis BESSIERE, PhD', 'role': 'CONTACT', 'email': 'francis.bessiere@chu-lyon.fr', 'phone': '0472357565', 'phoneExt': '+33'}, {'name': 'Francis BESSIERE, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital cardiologique Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '92350', 'city': 'Le Plessis-Robinson', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alice MALTRET, PhD', 'role': 'CONTACT', 'email': 'alice.maltret@gmail.com', 'phone': '01 40 94 25 45', 'phoneExt': '+33'}, {'name': 'Alice MALTRET, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Marie Lannelongue', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}, {'zip': '13385', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Linda KOUTBI, PhD', 'role': 'CONTACT', 'email': 'Rita.KOUTBI@ap-hm.fr', 'phone': '04 91 38 65 75', 'phoneExt': '+33'}, {'name': 'Linda KOUTBI, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75015', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Victor WALDMANN, PhD', 'role': 'CONTACT', 'email': 'victor.waldmann@aphp.fr', 'phone': '01 44 49 43 44', 'phoneExt': '+33'}, {'name': 'Victor WALDMANN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas DERVAL, PhD', 'role': 'CONTACT', 'email': 'nicolas.derval@chu-bordeaux.fr'}, {'name': 'Nicolas DERVAL, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Cardiologique du Haut Lévêque - Service de cardiologie-électrophysiologie et stimulation cardiaque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '33604', 'city': 'Pessac', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal AMEDRO, PU,PH', 'role': 'CONTACT', 'email': 'pascal.amedro@chu-bordeaux.fr'}, {'name': 'Pascal AMEDRO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Cardiologique du Haut Lévêque - Service des maladies cardio-vasculaires congénitales', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '31076', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas COMBES, PhD', 'role': 'CONTACT', 'email': 'ncombes@clinique-pasteur.com', 'phone': '05 62 21 16 45', 'phoneExt': '+33'}, {'name': 'Nicolas COMBES, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Francis BESSIERE, Dr', 'role': 'CONTACT', 'email': 'francis.bessiere@chu-lyon.fr', 'phone': '04 72 35 75 65', 'phoneExt': '0033'}, {'name': 'Nawel BABOURI, CRA', 'role': 'CONTACT', 'email': 'nawel.babouri@chu-lyon.fr', 'phone': '04.26.73.93.83', 'phoneExt': '0033'}], 'overallOfficials': [{'name': 'Francis BESSIERE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital cardiologique Louis Pradel - Hospices Civils de Lyon Service Rythmologie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}