Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-03 @ 8:00 AM
Study NCT ID:
NCT06842160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Electrocardiogram data、Photoplethysmography data'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2036-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Stroke', 'timeFrame': 'March 30, 2025 to March 30, 2035', 'description': 'The rate of stroke occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of strokes per participant).'}, {'measure': 'Incidence of Heart Failure', 'timeFrame': 'March 30, 2025 to March 30, 2035', 'description': 'The rate of heart failure occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of heart failure episodes per participant).'}, {'measure': 'All-Cause Mortality Rate', 'timeFrame': 'March 30, 2025 to March 30, 2035', 'description': 'The rate of all-cause mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of deaths per participant).'}, {'measure': 'Cardiovascular Mortality Rate', 'timeFrame': 'March 30, 2025 to March 30, 2035', 'description': 'The rate of cardiovascular-related mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of cardiovascular-related deaths per participant).'}, {'measure': 'Rate of Rehospitalization', 'timeFrame': 'March 30, 2025 to March 30, 2035', 'description': 'The rate of rehospitalization due to any medical cause in the study population. The unit of measure will be the frequency of events (e.g., number of rehospitalization events per participant).'}, {'measure': 'Incidence of Bleeding Events', 'timeFrame': 'March 30, 2025 to March 30, 2035', 'description': 'The rate of bleeding events (such as major or minor bleeding) in the study population. The unit of measure will be the frequency of events (e.g., number of bleeding events per participant).'}, {'measure': 'Postoperative Atrial Fibrillation Burden', 'timeFrame': 'March 30, 2025 to March 30, 2035', 'description': 'The frequency and severity of atrial fibrillation episodes observed in participants after a surgical procedure, measured using data collected by an intelligent heart rate monitoring watch utilizing a PPG algorithm. The unit of measure will be frequency of events (e.g., number of episodes per participant).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation Burden、 Catheter Ablation', 'Photoplethysmography', 'Wearable devices.'], 'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a smart electrocardiogram watch based on the PPG algorithm in monitoring the atrial fibrillation burden of patients after catheter ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have undergone catheter ablation for atrial fibrillation and meet age and health standards are able to use electrocardiographic watches for long-term monitoring', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Atrial fibrillation patients diagnosed by electrocardiogram\n2. Received catheter ablation procedure\n3. Willing to use long-range electrocardiogram monitoring equipment\n\nExclusion Criteria:\n\n1.Patients who are allergic to electronic devices or unable to wear watches'}, 'identificationModule': {'nctId': 'NCT06842160', 'acronym': 'Polaris-AFCA', 'briefTitle': 'Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation', 'orgStudyIdInfo': {'id': 'KS2024101'}, 'secondaryIdInfos': [{'id': 'KS2024101', 'type': 'OTHER', 'domain': 'Chengdu Xinjikang Technology Co., Ltd'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'intervention group', 'type': 'DEVICE', 'description': 'A smart electrocardiogram watch based on the PPG algorithm for monitoring atrial fibrillation load after catheter ablation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Song ZUO, M.D', 'role': 'CONTACT', 'email': 'song_zuo@126.com', 'phone': '1880142775'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Song Zuo, M.D', 'role': 'CONTACT', 'email': 'song_zuo@126.com', 'phone': '1880142775'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}