Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT01673256
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2012-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
DEtermining Accuracy and TrEnding CharacTerization of AF
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': 'kbrunner02@sjm.com', 'phone': '651.756.3482', 'title': 'Kyle Brunner', 'organization': 'St. Jude Medical Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SJM Confirm ICM Observational Group', 'description': 'SJM Confirm ICM', 'otherNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SJM Confirm ICM Observational Group', 'description': 'SJM Confirm ICM'}], 'classes': [{'title': 'Duration Sensitivity', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000', 'lowerLimit': '71.6', 'upperLimit': '96.1'}]}]}, {'title': 'Duration Positive Predictive Value', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 days after Holter starts', 'description': 'Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.\n\nPositive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SJM Confirm ICM Observational Group', 'description': 'SJM Confirm ICM'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SJM Confirm ICM Observational Group', 'description': 'SJM Confirm ICM'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.4', 'spread': '16.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2012-08-22', 'resultsFirstSubmitDate': '2015-01-05', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-16', 'studyFirstPostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.', 'timeFrame': '4 days after Holter starts', 'description': 'Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.\n\nPositive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject has been implanted with a SJM Confirm ICM, DM2102.\n* The subject has or is suspected to have paroxysmal AF.\n* The subject is ≥ 18 years of age.\n* The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).\n\nExclusion Criteria:\n\n* The subject has persistent (\\>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF \\>1 year) or permanent AF (not attempting to restore sinus rhythm).\n* The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).\n* The subject has a contraindication to Holter recording.\n* The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.\n* The subject is unable to comply with the follow up schedule.\n* The subject is participating in another investigational device or drug investigation.\n* The subject is pregnant or is planning to become pregnant during the duration of the investigation.'}, 'identificationModule': {'nctId': 'NCT01673256', 'briefTitle': 'DEtermining Accuracy and TrEnding CharacTerization of AF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'DEtermining Accuracy and TrEnding CharacTerization of AF', 'orgStudyIdInfo': {'id': 'DETECT AF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SJM Confirm ICM Observational Group', 'interventionNames': ['Device: SJM Confirm ICM']}], 'interventions': [{'name': 'SJM Confirm ICM', 'type': 'DEVICE', 'armGroupLabels': ['SJM Confirm ICM Observational Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Rhön-Klinikum, Herz- und Gefäß-Klinik', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz -und Diabeteszentrum', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite, Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'University of Dresden - Heart Center', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum Frankfurt Höchst GmbH', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '85049', 'city': 'Ingolstadt', 'country': 'Germany', 'facility': 'Klinikum Ingolstadt GmbH', 'geoPoint': {'lat': 48.76508, 'lon': 11.42372}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '80331', 'city': 'Munich', 'country': 'Germany', 'facility': 'Isar Heart Center', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Singen', 'country': 'Germany', 'facility': 'Hegau-Bodensee-Kliniken', 'geoPoint': {'lat': 47.75935, 'lon': 8.8403}}, {'city': 'Villingen-Schwenningen', 'country': 'Germany', 'facility': 'Schwarzwald-Baar Klinikum GmbH', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}, {'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Hospital', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Hagahospital', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}], 'overallOfficials': [{'name': 'Thorsten Lewalter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isar Heart Center Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}