Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT00888667
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2009-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal EGM Configuration for Morphology Discrimination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018879', 'term': 'Ventricular Premature Complexes'}], 'ancestors': [{'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Patient population was not available', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2009-04-24', 'studyFirstSubmitQcDate': '2009-04-24', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% morphology match', 'timeFrame': 'acute', 'description': 'off line analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICD patients with PVCs and EGM recordings'], 'conditions': ['Premature Ventricular Complexes']}, 'descriptionModule': {'briefSummary': "The study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.\n\nHypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a dual chamber ICD and frequent PVCs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.\n2. Patients must be willing to sign an informed consent form.\n3. Patients must have frequent PVCs (minimum of 30/hour)\n\nExclusion Criteria:\n\n1. Known history of slow VT (under 160 bpm).\n2. Patients under the age of 18 years.\n3. Pregnant women.\n4. Pacemaker dependent rhythm.\n5. Ongoing angina pectoris.\n6. Current NYHA Class 3-4 heart failure.'}, 'identificationModule': {'nctId': 'NCT00888667', 'acronym': 'SVT Morphology', 'briefTitle': 'Optimal EGM Configuration for Morphology Discrimination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Optimal EGM Configuration for Morphology Discrimination', 'orgStudyIdInfo': {'id': 'HV001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICD patient with frequent PVCs', 'interventionNames': ['Other: Pacing interventions']}], 'interventions': [{'name': 'Pacing interventions', 'type': 'OTHER', 'description': '10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting', 'armGroupLabels': ['ICD patient with frequent PVCs']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Unity Health Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}