Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 1:55 PM
Study NCT ID:
NCT00717106
Status:
UNKNOWN
Last Update Posted:
2009-05-05
First Post:
2008-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of the Sleuth Implantable ECG Monitoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}, {'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': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'lastUpdateSubmitDate': '2009-05-04', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-15', 'lastUpdatePostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to diagnosis', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ILR', 'ECG monitoring', 'cardiac arrhythmia', 'syncope', 'presyncope', 'fainting'], 'conditions': ['Syncope', 'Presyncope', 'Fainting', 'Cardiac Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cardiology or primary care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias\n* Patients who experience transient symptoms that may suggest a cardiac arrhythmia\n\nExclusion Criteria:\n\n* Patients that have had a myocardial infarction (MI) \\< 30 days prior to implant'}, 'identificationModule': {'nctId': 'NCT00717106', 'acronym': 'OBSERV-ECG', 'briefTitle': 'Observational Study of the Sleuth Implantable ECG Monitoring System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Transoma Medical'}, 'officialTitle': 'Observational Study of the Sleuth Implantable ECG Monitoring System', 'orgStudyIdInfo': {'id': 'CLP-007'}}, 'contactsLocationsModule': {'locations': [{'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21502', 'city': 'Cumberland', 'state': 'Maryland', 'country': 'United States', 'facility': 'Western Maryland Health Systems', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'zip': '48446', 'city': 'Lapeer', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cardiology Consultants of East Michigan', 'geoPoint': {'lat': 43.05142, 'lon': -83.31883}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's - Roosevelt", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'SUMMA-NEOCS Health Systems', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Main Line Health - Lankenau Hospital', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Cardiac Arrhythmias', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Morgantown Internal Medicine Group', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Wim Stegink', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Transoma Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Transoma Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wim Stegink', 'oldOrganization': 'Transoma Medical'}}}}