Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-27 @ 3:44 AM
Study NCT ID:
NCT01977703
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2013-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-13', 'studyFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first ICD shock following LVAD implant', 'timeFrame': 'Within 12 months following LVAD implant'}], 'secondaryOutcomes': [{'measure': 'Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection', 'timeFrame': 'Within 12 months following LVAD implant', 'description': 'Number of ATP occurrences'}, {'measure': 'Frequency of ICD generator change prior to definitive therapy', 'timeFrame': 'Within 12 months following LVAD implant', 'description': 'Number of patients requiring ICD generator change'}, {'measure': 'Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes', 'timeFrame': 'Within 12 months following LVAD implant', 'description': 'Battery voltage and battery life measured in days'}, {'measure': 'Frequency of arrhythmic syncope', 'timeFrame': 'Within 12 months following LVAD implant', 'description': 'Number of syncope occurrences'}, {'measure': 'Hospitalization frequency for decompensated congestive heart failure', 'timeFrame': 'Within 12 months following LVAD implant', 'description': 'Number of hospitalizations'}, {'measure': 'Determine survival to heart transplantation following LVAD implant', 'timeFrame': 'Within 12 months following LVAD implant', 'description': 'Number of patients, post LVAD implant, to receive heart transplant and number of survival days post implant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Advanced Heart Failure', 'LVAD', 'Left Ventricular Assist Device', 'Heart-Assist Devices'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '29475875', 'type': 'DERIVED', 'citation': 'Richardson TD, Hale L, Arteaga C, Xu M, Keebler M, Schlendorf K, Danter M, Shah A, Lindenfeld J, Ellis CR. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device. J Am Heart Assoc. 2018 Feb 23;7(5):e007748. doi: 10.1161/JAHA.117.007748.'}]}, 'descriptionModule': {'briefSummary': 'We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Age ≥ 18\n* Advanced Heart Failure\n* Scheduled for Heartmate II LVAD implant\n* With existing ICD\n\nExclusion:\n\n-Age \\< 18'}, 'identificationModule': {'nctId': 'NCT01977703', 'briefTitle': 'Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).', 'orgStudyIdInfo': {'id': '131336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional ICD Programming', 'description': 'ICD will be set to pre-LVAD settings post LVAD implant.', 'interventionNames': ['Other: Traditional ICD Programming']}, {'type': 'EXPERIMENTAL', 'label': 'Ultra Conservative ICD Programming', 'description': 'ICD will be set to ultra conservative settings post LVAD implant.', 'interventionNames': ['Other: Ultra Conservative ICD Programming']}], 'interventions': [{'name': 'Ultra Conservative ICD Programming', 'type': 'OTHER', 'armGroupLabels': ['Ultra Conservative ICD Programming']}, {'name': 'Traditional ICD Programming', 'type': 'OTHER', 'armGroupLabels': ['Traditional ICD Programming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Christopher Ellis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thoratec Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christopher Ellis', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}