Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-05 @ 6:19 PM
Study NCT ID:
NCT00558857
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2007-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Substrate Mapping (DSM) for Ischemic VT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2007-11-14', 'studyFirstSubmitQcDate': '2007-11-14', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ischemic Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Results from this study will be used to determine if further clinical investigation is warranted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have an ICD or CRT-D device\n* Had at least 3 documented device therapies to treat VT over last 3 months\n* Clinical VT is confirmed or suspected to be of ischemic origin\n* Scheduled for VT ablation procedure\n* LVEF \\> or = 20%\n\nExclusion Criteria:\n\n* Inadequate AAD washout (amiodarone should be maintained at current dose)\n* Unstable angina\n* Active ischemia\n* Cardiac surgery within prior 2 months\n* Evidence of infection\n* Prosthetic mitral or aortic valve or mitral/aortic valvular heart disease requiring surgical intervention\n* History of embolic event\n* Myocardial infarction within prior 6 weeks\n* Enrolled in another study\n* Recurrent sepsis or otherwise not a candidate for catheterization\n* Hypercoagulable state or inability to tolerate heparin therapy during procedure\n* Has had an atriotomy or ventriculotomy within prior 4 months\n* Life expectancy \\< 6 months\n* Class IV NYHA classification'}, 'identificationModule': {'nctId': 'NCT00558857', 'acronym': 'DSM', 'briefTitle': 'Dynamic Substrate Mapping (DSM) for Ischemic VT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia', 'orgStudyIdInfo': {'id': '065.5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DSM', 'description': 'Treatment using DSM to guide ablation', 'interventionNames': ['Device: Dynamic Substrate Mapping-guided ablation']}], 'interventions': [{'name': 'Dynamic Substrate Mapping-guided ablation', 'type': 'DEVICE', 'description': 'Radiofrequency ablation', 'armGroupLabels': ['DSM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital at the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'David Callans, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Jason Jacobson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Donna Godejohn', 'oldOrganization': 'St. Jude Medical'}}}}