Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT00294034
Status:
COMPLETED
Last Update Posted:
2007-03-27
First Post:
2006-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 950}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-03-26', 'studyFirstSubmitDate': '2006-02-16', 'studyFirstSubmitQcDate': '2006-02-16', 'lastUpdatePostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Registry', 'Pacemaker', 'Diagnostics'], 'conditions': ['Pacemaker', 'Bradycardia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.', 'detailedDescription': 'The purpose of this registry is to gain a better understanding of how diagnostic capabilities in four Vitatron pacemakers (Selection AFm, Clarity, C-Series, and T-Series) are being utilized for the clinical management of a general pacing population. Pacemaker information and health status is collected from all patients enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Class I or Class II indication for dual chamber pacing\n\nExclusion Criteria:\n\n* Has an ICD or is a known candidate for an ICD'}, 'identificationModule': {'nctId': 'NCT00294034', 'briefTitle': 'VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies', 'orgStudyIdInfo': {'id': '197'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pacemaker', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Hyannis', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 41.65289, 'lon': -70.2828}}, {'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'city': 'Bay Shore', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.7251, 'lon': -73.24539}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'city': 'Barberton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.01283, 'lon': -81.60512}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'city': 'Massillon', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 40.79672, 'lon': -81.52151}}, {'city': 'Middletown', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.51506, 'lon': -84.39828}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'city': 'Waukesha', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.01168, 'lon': -88.23148}}], 'overallOfficials': [{'name': 'Norman Jaffe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Onondaga Hill Cardiovascular Group'}, {'name': 'Luis Caceres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prairie Cardiovascular Consultants'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'Medtronic BRC', 'class': 'INDUSTRY'}]}}}