Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:50 PM
Study NCT ID:
NCT01423994
Status:
COMPLETED
Last Update Posted:
2019-05-16
First Post:
2011-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Syncope: Pacing or Recording in the Later Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-15', 'studyFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2011-08-25', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure will be a composite of Major Adverse Study-Related Events (MASRE) in a 2-year observation period.', 'timeFrame': '2 years', 'description': 'MASRE will capture the major consequences ensuing from both strategies, including 1) syncope, 2) symptomatic bradycardias, 3) asymptomatic complete heart block, 4) acute and chronic pacemaker and ILR complications, and 5) death.'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome measures will include total number of syncopal spells.', 'timeFrame': '2 years'}, {'measure': 'Secondary outcome measures will include the likelihood of a first recurrence of syncope.', 'timeFrame': '2 years'}, {'measure': 'Secondary outcome measures will include the physical trauma due to syncope.', 'timeFrame': '2 years'}, {'measure': 'Secondary outcome measures will include quality of life of the participants.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['syncope', 'fainting', 'implantable loop recorder', 'pacemaker', 'heart block', 'bifascicular heart block'], 'conditions': ['Syncope', 'Heart Block', 'Conduction Disorder of the Heart']}, 'referencesModule': {'references': [{'pmid': '35210082', 'type': 'DERIVED', 'citation': 'Sheldon R, Talajic M, Tang A, Becker G, Essebag V, Sultan O, Baranchuk A, Ritchie D, Morillo C, Krahn A, Brignole M, Manns B, Maxey C, Raj SR; SPRITELY Investigators. Randomized Pragmatic Trial of Pacemaker Versus Implantable Cardiac Monitor in Syncope and Bifascicular Block. JACC Clin Electrophysiol. 2022 Feb;8(2):239-248. doi: 10.1016/j.jacep.2021.10.003. Epub 2021 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits, and probably is responsible for CDN $250 million in health care spending each year. It is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. It is a particular problem for older people, partly because of increased frailty, and partly because of a difficult differential diagnosis. One of the causes in older adults is intermittent complete heart block in the setting of bifascicular heart block, but they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome, and several neurally mediated syncopes. Often treatment decisions should be made before the true cause is apparent.', 'detailedDescription': 'There are two general approaches to the patient with syncope and bifascicular block, a common substrate for intermittent heart block. The first is to assume that intermittent heart block is the cause, and simply implant a pacemaker. The second is to implant a digital ECG loop recorder with a lifespan of 2 - 3 years, determine the rhythm abnormalities during the next faint, and treat accordingly. Both approaches expose patients to a risk of fainting and its sequelae, and both carry device-related complications.Which approach is superior is unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients are eligible if they have:\n\n* \\>1 syncopal spell within 1 year preceding enrollment, and\n* bifascicular block on a 12-lead ECG, and\n* Age \\> 50 years and\n* written informed consent. Syncope will be defined based on history using a standardized form.\n\nExclusion Criteria:\n\n-Patients will be excluded if they have criteria related to study strategies, including:\n\n1. previous pacemaker, ICD, or Implantable Loop Recorder in situ,\n2. ACC/AHA/HRS Class I indication for permanent pacing or ICD implantation,\n3. left ventricular ejection fraction \\< 35% mandating ICD therapy,\n4. contra-indication to a transvenous pacemaker such as artificial tricuspid valve or active sepsis.\n\n -Patients will also be excluded if a potential competing cause of syncope poses a threat to life, such as:\n5. hypertrophic cardiomyopathy,\n6. documented sustained ventricular tachycardia or\n7. inducible, sustained monomorphic ventricular tachycardia on EP study.\n\n -They will be excluded if they have:\n8. a history of myocardial infarction within 3 months prior to enrollment, and\n9. a major chronic co-morbid medical condition that would preclude 24 months of follow-up.'}, 'identificationModule': {'nctId': 'NCT01423994', 'acronym': 'Spritely', 'briefTitle': 'Syncope: Pacing or Recording in the Later Years', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Syncope: Pacing or Recording in the Later Years (SPRITELY)', 'orgStudyIdInfo': {'id': 'CIHR#230880'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'implantable loop recorder', 'interventionNames': ['Procedure: implantable loop recorder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pacemaker', 'interventionNames': ['Procedure: pacemaker']}], 'interventions': [{'name': 'pacemaker', 'type': 'PROCEDURE', 'description': "A single or dual chamber pacemaker will be implanted according to the manufacturer's instructions for use with standard techniques.\n\nEither a single or dual chamber pacemaker will be permitted according to local practice unless the patient is in chronic or persistent atrial fibrillation, in which case a single chamber pacemaker will be used. The pacemaker configuration will be at the discretion of the investigator.\n\nSingle chamber ventricular pacemakers will be programmed to activity responsiveness off in VVI mode, rates 50-120 bpm.\n\nDual chamber pacemaker programming will be to DDD mode (50-120) with mode switch on.", 'armGroupLabels': ['pacemaker']}, {'name': 'implantable loop recorder', 'type': 'PROCEDURE', 'description': 'The implantable loop recorder will be programmed for automatic detection using settings of Low Heart Rate \\<50 bpm, High Heart Rate \\>165 bpm, and Pause \\> 3 seconds.', 'armGroupLabels': ['implantable loop recorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1K8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V8R 4R2', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria Heart Institute', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'St. Boniface Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Horizon Health Network New Brunswick', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'L8L 8E7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mc Master University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 3K7', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'S4P 0W5', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Prairie Vascular Research Inc.', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'city': 'Kitakyushu', 'country': 'Japan', 'facility': 'University of Occupational and Environmental Health', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Shwa General Hospital', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}], 'overallOfficials': [{'name': 'Robert S Sheldon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Vanderbilt University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiac Sciences, Medicine and Medical Genetics', 'investigatorFullName': 'Dr. Bob Sheldon', 'investigatorAffiliation': 'University of Calgary'}}}}