Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-30 @ 1:28 AM
Study NCT ID:
NCT01917266
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2013-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2013-07-30', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of patients with the left ventricle (LV) lead implanted at the site of latest mechanical activation', 'timeFrame': 'This outcome measure will be assessed after an off-line analysis immediately after implant'}], 'secondaryOutcomes': [{'measure': 'Response to Cardiac Resynchronization Therapy (CRT) as defined by percent change in end-systolic volume (ESV) at 6-month follow-up relative to baseline.', 'timeFrame': '6 months after implant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in subjects with concordant versus discordant left ventricular (LV) lead position as compared to the site of latest mechanical activation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart failure patients indicated for a Cardiac Resynchronization Therapy (CRT) device', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be scheduled to undergo implant of a Cardiac Resynchronization Therapy (CRT) system with approved standard indication per accepted guidelines as a new implant or an upgrade from an existing Implantable Cardioverter Defibrillator (ICD) or pacemaker with no prior left ventricular lead placement\n* Be in sinus rhythm at the time of enrollment\n* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations\n\nExclusion Criteria:\n\n* Have persistent or permanent atrial fibrillation\n* Be in New York Heart Association (NYHA) IV functional class\n* Have prior left ventricular (LV) lead implant\n* Be pacemaker-dependent\n* Have a recent myocardial infarction within 40 days prior to enrollment\n* Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months\n* Have had a recent Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months prior to enrollment\n* Have had intravenous inotropic support in the last 30 days\n* Exhibit Cheyne-Stokes respiration\n* Be less than 18 years of age\n* Be pregnant or planning to become pregnant during the duration of the investigation\n* Be currently participating in any other clinical investigation'}, 'identificationModule': {'nctId': 'NCT01917266', 'briefTitle': 'Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide', 'orgStudyIdInfo': {'id': 'SJM-CIP-10084'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Concordant'}, {'label': 'Discordant'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}