Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT00328705
Status:
COMPLETED
Last Update Posted:
2008-02-13
First Post:
2006-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017147', 'term': 'Defibrillators, Implantable'}], 'ancestors': [{'id': 'D047548', 'term': 'Defibrillators'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-11', 'studyFirstSubmitDate': '2006-05-19', 'studyFirstSubmitQcDate': '2006-05-19', 'lastUpdatePostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular fibrillation (VF) detection time'}, {'measure': 'Ventricular Capture Management accuracy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sensing', 'Capture Management', 'Heart Failure', 'ICD Indication'], 'conditions': ['Heart Diseases']}, 'descriptionModule': {'briefSummary': 'This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.', 'detailedDescription': 'The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device\n* Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.\n\nExclusion Criteria:\n\n* Patients who have 3rd degree heart block, as assessed by the investigator\n* Patients who have a mechanical tricuspid heart valve\n* Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device'}, 'identificationModule': {'nctId': 'NCT00328705', 'briefTitle': 'D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management', 'orgStudyIdInfo': {'id': '209'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implantable Cardioverter Defibrillator', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Coon Rapids', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.11997, 'lon': -93.28773}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Cole Hannon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medtronic CRDM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Cole Hannon', 'oldOrganization': 'CRDM clinical research'}}}}