Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT04926857
Status:
TERMINATED
Last Update Posted:
2025-08-01
First Post:
2021-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DEFINE AFib (Atrial Fibrillation)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nirav.a.patel@medtronic.com', 'phone': '1 (800) 633-8766', 'title': 'Nirav Patel', 'organization': 'Medtronic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality was monitored from time of enrollment to completion of study (up to 2.6 years of follow-up). Adverse events were not required and were not collected to meet the objectives of this study.', 'description': 'All cause mortality was monitored, but adverse events were not required and were not collected to meet the objectives of this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled Patients', 'description': 'Patients that completed a survey on the study App that confirmed that they met the inclusion/exclusion criteria of the study and that they read and agreed with the informed consent.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 970, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '864', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Training and Testing Partitions', 'description': 'The set of enrolled patients that had enough device follow-up for a lead-in portion and a prediction portion was used to develop a prediction model for increase healthcare utilizations. There were 864 total patients with sufficient device follow-up. Patients were partitioned into a training set (N=601) and a testing set (N=263). A predictive model was built with the training set and assessed for predictive value in the testing set.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '0.81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion (2 years of enrollment, up to 2.6 years of follow-up)', 'description': 'Primary objective is to evaluate whether summary and episodic measurements collected by market-released LINQ ICMs are able to predict increased AF-related healthcare utilization (HCU), which are confirmed healthcare visits in the inpatient hospital, outpatient hospital, clinic/office, emergency department, or other care location (including remote visits) where AF was a reason or suspected reason for healthcare interaction.\n\nA predictive model was trained on 70% of the patients with adequate data available and assessed in a validation data set of the remaining 30% of patients, using rolling 60 day blocks. In each block, measurements in the first 30 days were used to predict whether confirmed HCU occurred in the trailing 30 days. Predictive value was assessed using sensitivity, specificity and other measurements within a confusion matrix as well as an area under the receiver operator curve, balancing the sensitivity and specificity. Outcome measure entered here will be AUROC.', 'unitOfMeasure': 'Proportion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled Patients', 'description': 'Patients that completed a survey on the study App that confirmed that they met the inclusion/exclusion criteria of the study and that they read and agreed with the informed consent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '973'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '864'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Study product no longer in use', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'Inadequate data to address primary objective', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'During study execution, there was a sponsor decision to end the study earlier, so the study enrolled far less than the 5000 enrollments specified by the protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '970', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled Patients', 'description': 'Patients that completed a survey on the study App that confirmed that they met the inclusion/exclusion criteria of the study and that they read and agreed with the informed consent.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '276', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '694', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '414', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '556', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '777', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '136', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '970', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Reason for enrollment', 'classes': [{'title': 'AF Management', 'categories': [{'measurements': [{'value': '584', 'groupId': 'BG000'}]}]}, {'title': 'AF Ablation', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}]}]}, {'title': 'Cryptogenic Stroke', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}, {'title': 'Palpitations', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Suspected AF', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients in the study received a LINQ device for one of the following reasons: AF ablation, AF management, cryptogenic stroke, palpitations or suspected AF', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Due to eligibility survey responses permanently missing for 3 subjects, 970 of the 973 subject enrollments are included in all analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-29', 'size': 3024413, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-07T14:24', 'hasProtocol': True}, {'date': '2023-01-10', 'size': 1553665, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-06T13:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 973}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2021-01-04', 'resultsFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-31', 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction.', 'timeFrame': 'Through study completion (2 years of enrollment, up to 2.6 years of follow-up)', 'description': 'Primary objective is to evaluate whether summary and episodic measurements collected by market-released LINQ ICMs are able to predict increased AF-related healthcare utilization (HCU), which are confirmed healthcare visits in the inpatient hospital, outpatient hospital, clinic/office, emergency department, or other care location (including remote visits) where AF was a reason or suspected reason for healthcare interaction.\n\nA predictive model was trained on 70% of the patients with adequate data available and assessed in a validation data set of the remaining 30% of patients, using rolling 60 day blocks. In each block, measurements in the first 30 days were used to predict whether confirmed HCU occurred in the trailing 30 days. Predictive value was assessed using sensitivity, specificity and other measurements within a confusion matrix as well as an area under the receiver operator curve, balancing the sensitivity and specificity. Outcome measure entered here will be AUROC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform. This study will enroll approximately 5,000 patients in the United States who have a Reveal LINQ or LINQ II ICM (or future market-released LINQ devices) and an Apple® iPhone® with iOS version 13 or higher. Interested participants will be screened through the Medtronic Discovery app and those eligible will complete an app-based informed consent. Participants will receive health-focused and quality of life surveys at variable timepoints. DEFINE AFib will measure healthcare interactions using administered surveys to identify said interactions. The Medtronic Discovery app will provide participants with a summary of their ICM data. Participants will be followed up to 5 years or to the end of their ICM service life.', 'detailedDescription': "The purpose of this study is to evaluate the association between complex patterns of device-detected AF and other summary and episodic measurements collected by the market- released LINQ ICM device and AF-related healthcare utilization, quality of life, AF-related symptoms, and specific clinical outcomes in patients with a market-released LINQ ICM. The Medtronic Discovery app will be used to collect data both (1) via the iPhone® through patient-reported health surveys and Bluetooth-enabled devices connected through the Apple Health app and (2) data accessed through or stored on the phone pertaining to health records, activity, and other lifestyle data. Secondarily, this study will examine associations between clinical procedures, medications and lifestyle actions taken and their impact on device-detected AF. Additionally, this study will help Medtronic evaluate patients' interaction with reports generated from health data collected by the market-released LINQ ICM. This study will improve our understanding of how data from the LINQ family of devices can be used to guide the management of AF patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Atrial Fibrillation and a LINQ device', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Patients with a LINQ ICM who have a self-reported history of AF and who have received an ICM for the following device-logged indications, categorized into the following discrete groups:\n\n * AF management: AF management and post-ablation management indications\n * Suspected AF: Suspected AF and palpitations indications\n * Stroke: Cryptogenic stroke indication\n* Individual Access and ability to use an Apple iPhone® compatible with Medtronic's research app (iOS® v. 13.X or higher)\n* Patient is willing and able to comply with the protocol, including CareLink transmissions (requires adequate connectivity), remotely administered instructions, and remote survey participation\n* Patient is 22 years of age or older\n* Located in the United States, with CareLink managed through servers located in United States (50 states or District of Columbia)\n* Valid email address from self-report at enrollment\n* Patient must be able to read and write in English\n\nExclusion Criteria Patients with \\> 24 months elapsed time from recorded LINQ device implant or \\> 48 months elapsed from recorded LINQ II implant date"}, 'identificationModule': {'nctId': 'NCT04926857', 'acronym': 'DEFINE AFib', 'briefTitle': 'DEFINE AFib (Atrial Fibrillation)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'DEFINE AFib Atrial Fibrillation - Development of a Predictive Model for Future Health Care Utilization From Measurements Collected From an Implantable Cardiac Monitor.', 'orgStudyIdInfo': {'id': 'MDT20024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-Interventional', 'type': 'OTHER', 'description': 'Non-Interventional'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Saint Joseph Heritage Hospital', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Desert Heart Rhythm Consultants', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '33462-6614', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Electrophysiology Associates', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33432', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiac Arrhythmia Service', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'HCA Healthcare', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': "Stormont Vail Health Cotton O'Neil Clinical Research Center", 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Heart Specialists', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Jackson Heart Clinic', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '07450-2726', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Brooklyn Methodist Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11743', 'city': 'Huntington', 'state': 'New York', 'country': 'United States', 'facility': 'Huntington Hospital', 'geoPoint': {'lat': 40.86815, 'lon': -73.42568}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Hospital Long Island', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10601', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'White Plains Hospital Medical Center', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cone Health', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Heart Hospital Research Foundation', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18018', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Luke's Cardiology Associates", 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Stern Cardiovascular Foundation', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascension Seton Heart Institute Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '98225', 'city': 'Bellingham', 'state': 'Washington', 'country': 'United States', 'facility': 'PeaceHealth Saint Joseph Medical Center', 'geoPoint': {'lat': 48.75955, 'lon': -122.48822}}], 'overallOfficials': [{'name': 'Jonathan Piccini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}