Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 8:27 PM
Study NCT ID:
NCT06847932
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D018880', 'term': 'Atrial Premature Complexes'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14726}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latent atrial fibrillation', 'timeFrame': 'Within 90 days after enrollment.', 'description': 'The primary outcome, latent atrial fibrillation, is a composite of new diagnoses of AF/AFL, atrial arrhythmia with high AF risk, including PACs ≥ 500/24hr, burst PACs \\> 20 beats, and non-sustained AF/AFL, within 90 days after enrollment. The results will be demonstrated as the rate of diagnoses of latent atrial fibrillation.'}], 'secondaryOutcomes': [{'measure': 'Antiarrhythmic treatment', 'timeFrame': 'Within 180 days after enrollment.', 'description': 'Antiarrhythmic treatment may include newly prescribed beta-blockers or non-dihydropyridine calcium channel blockers, class Ia, Ic, and III antiarrhythmic drugs, and catheter ablation. Physicians can determine whether a patient requires antiarrhythmic treatment through clinical practice. The outcome is the rate of initiation of antiarrhythmic treatment.'}, {'measure': '90-days New diagnoses of atrial fibrillation/atrial flutter', 'timeFrame': 'Within 90 days after enrollment.', 'description': 'New diagnoses of atrial fibrillation or atrial flutter are defined as those documented by a 12-lead electrocardiogram or by continuous cardiac rhythm monitoring for ≥ 30 seconds. The result will be presented as the rate of new diagnoses of atrial fibrillation or atrial flutter.'}, {'measure': 'Atrial arrhythmia with high AF risk', 'timeFrame': 'Within 90 days after enrollment.', 'description': 'Atrial arrhythmia with high AF risk is defined by the following criteria: premature atrial complexes more than 500 beats in 24 hours as recorded by a continuous cardiac rhythm monitor; burst premature atrial complexes exceeding 20 beats as documented in a continuous cardiac rhythm monitor or a 12-lead electrocardiogram, or documented non-sustained AF/AFL in either a continuous cardiac rhythm monitor or a 12-lead electrocardiogram. The result will be presented as the rate of diagnoses of atrial arrhythmia with high AF risk.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation (AF)', 'Premature Atrial Complexes', 'Atrial Arrhythmias', 'Artificial Intelligence (AI)', 'Electrocardiogram']}, 'descriptionModule': {'briefSummary': 'Our study aimed to use an AF-predict AI-ECG alert system to help physicians identify patients who need to wear a continuous cardiac rhythm monitor for new diagnoses of atrial fibrillation (AF), atrial flutter (AFL), or atrial arrhythmia with high AF risk, including premature atrial complexes (PAC) ≥ 500/24hr, burst PACs \\> 20 beats, non-sustained AF/AFL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '85 Days', 'minimumAge': '40 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the inpatient department or the outpatient department\n* Patients need to have at least one electrocardiogram within one year\n\nExclusion Criteria:\n\n* Diagnosis of atrial fibrillation/atrial flutter\n* History of atrial fibrillation/atrial flutter catheter ablation\n* Patients with cardiac implantable electronic devices\n* Any documented electrocardiogram showed atrial fibrillation/atrial flutter and pacing rhythm\n* History of received rhythm control medications for atrial arrhythmia, including Class I and Class III antiarrhythmic drugs\n* Any reasons indicate for anti-coagulant agents, including vitamin K antagonist and non-vitamin K antagonist oral anticoagulant'}, 'identificationModule': {'nctId': 'NCT06847932', 'acronym': 'LATENT', 'briefTitle': 'Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development', 'organization': {'class': 'OTHER', 'fullName': 'National Defense Medical Center, Taiwan'}, 'officialTitle': 'Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'A202205179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AF-predict AI-ECG alert system', 'description': "All the patients' ECGs will receive AF-predict AI-ECG analysis. According to the AI-ECG analysis results, those with at least one high-risk ECG within one year will be called back and asked to undergo a continuous cardiac rhythm monitor for up to 7 days. Otherwise, the physicians can review the AI-ECG analysis results for all the patients in the intervention group.", 'interventionNames': ['Other: AF-predict AI-ECG alert system guided management']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Patients will receive the standard care, and their ECGs will not be analyzed by AI-ECG before the end of the study.'}], 'interventions': [{'name': 'AF-predict AI-ECG alert system guided management', 'type': 'OTHER', 'description': 'AF-predict AI-ECG alert system', 'armGroupLabels': ['AF-predict AI-ECG alert system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yuan-Hao Chen', 'role': 'CONTACT', 'email': 'chenyh178@gmail.com', 'phone': '+886287923311'}, {'name': 'Chin Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chin Lin, PhD', 'role': 'CONTACT', 'email': 'xup6fup@mail.ndmctsgh.edu.tw', 'phone': '+886-2-8792-3100 Ext. 18574'}, {'name': 'ChiaoChin Lee, MD', 'role': 'CONTACT', 'email': 'chiaochinlee@hotmail.com', 'phone': '+886919614672'}], 'overallOfficials': [{'name': 'Chin Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Defense Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Defense Medical Center, Taiwan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chin Lin', 'investigatorAffiliation': 'National Defense Medical Center, Taiwan'}}}}