Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT07148934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Algorithm development for Seismocardiograph and Ballistocardiograph for detecting Supraventricular tachycardia', 'timeFrame': '2025-2027', 'description': 'Understanding and developing the algorithm to differentiate the supraventricular tachycardia (SVT) and sinus rhythm subjects based on seismocardiography and ballistocardiography signals.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supraventricular Tachycardia', 'Atrial Fibrillation', 'Seismocardiography', 'SmartPhone'], 'conditions': ['Supraventricular Tachycardia', 'Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the reliability of smartphone seismocardiography (SCG) and bed-based ballistocardiography (BCG) for detecting supraventricular tachycardia (SVT) in children aged 0-10 years. The performance of these methods will be compared to the gold standard of continuous telemetry ECG recording.', 'detailedDescription': 'This study aims to validate the use of a cardiac monitoring system, comprising a smartphone for seismocardiography (SCG) and a smart mattress for ballistocardiography (BCG), to detect supraventricular tachycardia (SVT) in children aged 0-10 years. Additionally, the study will compare heart rate and breathing rate measurements from these investigational devices against a Philips Intellivue X2 ECG Monitor, which serves as the gold standard. A convenience sample of up to 60 children (30 in the SVT group and 30 in the control group) will be recruited, and their parents will also be interviewed to explore their perceptions of arrhythmia monitoring. The primary objective is to develop and understand algorithms for differentiating SVT from sinus rhythm using SCG and BCG signals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'N=up to 60, 30 for the study (SVT) group and 30 for the control group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For children in Study(SVT) group:\n\n 1. received informed consent from both parents/guardians\n 2. the child is treated in the Pediatric wards of Tyks Lighthouse hospital\n 3. the child is between the age of 0-10 years\n 4. the child has diagnosed or suspected SVT.\n* For children in control group:\n\n 1. received informed consent from both parents/guardians\n 2. the child is treated in the Pediatric wards of Tyks Lighthouse hospital\n 3. the child is between the age of 0-10 years\n 4. child has not diagnosed with SVT\n\nExclusion Criteria:\n\n* All participant groups:\n\n 1. not reaching the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT07148934', 'briefTitle': 'Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study', 'orgStudyIdInfo': {'id': 'FIMEA/2025/002511-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study( SVT) Group', 'description': 'Children aged 0-10 years treated in the pediatric wards of Tyks Lighthouse Hospital with diagnosed or suspected supraventricular tachycardia (SVT).', 'interventionNames': ['Diagnostic Test: Smartphone seismographic recording and Bed Based Ballistocardiographic recordings']}, {'label': 'Control Group', 'description': 'Children aged 0-10 years treated in the pediatric wards of Tyks Lighthouse hospital who have not been diagnosed with SVT (i.e., have a normal sinus rhythm).', 'interventionNames': ['Diagnostic Test: Smartphone seismographic recording and Bed Based Ballistocardiographic recordings']}], 'interventions': [{'name': 'Smartphone seismographic recording and Bed Based Ballistocardiographic recordings', 'type': 'DIAGNOSTIC_TEST', 'description': 'A short recording of heart rhythm using a smartphone and bed-based ballistocardiogram.', 'armGroupLabels': ['Control Group', 'Study( SVT) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'contacts': [{'name': 'AJDAR ULLAH', 'role': 'CONTACT', 'email': 'ajulla@utu.fi', 'phone': '(+358)404776970'}, {'name': 'susanna Likitalo', 'role': 'CONTACT', 'email': 'susanna.m.likitalo@utu.fi'}], 'facility': 'University of Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of Department', 'investigatorFullName': 'Anna Axelin', 'investigatorAffiliation': 'University of Turku'}}}}