Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-04-17 @ 6:13 AM
Study NCT ID:
NCT02584595
Status:
WITHDRAWN
Last Update Posted:
2019-02-04
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2015-10-21', 'studyFirstSubmitQcDate': '2015-10-21', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Number of ICD shocks.', 'timeFrame': '12 months'}, {'measure': 'Quality of Life via Short Form Survey (SF-36)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tachycardia', 'Ventricular Tachycardia', 'Cardiac Arrhythmias', 'Cardiovascular Diseases', 'Heart Diseases'], 'conditions': ['Monomorphic Ventricular Tachycardia']}, 'descriptionModule': {'briefSummary': 'The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillation (CRT-D) systems.', 'detailedDescription': 'Approximately 50 centers worldwide will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.\n\nThis study provides a mechanism for sites to refer subjects for potential enrollment to the Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) Investigational Device Exemption (IDE) study (ClinicalTrials.gov NCT02130765).\n\nPatients receiving ICD or CRT-D device implant (or have received it within 30 days) may be enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The primary study population includes patients who meet all inclusion/exclusion criteria, has had or will have market-approved St. Jude Medical ICD or CRT-D device systems implanted, and has no history of MMVT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient is receiving a new SJM ICD or CRT-D implant system, which has study required programing capabilities and is appropriate for remote monitoring. Patients who have received the ICD or CRT-D up to 30 days prior to enrollment are also eligible.\n\nPatient consents to have a NIPS/EP study.\n\nPatient has documented Ejection Fraction (EF) \\< 50% and / or Right Ventricular (RV) dysfunction.\n\nPatient has documented structural cardiomyopathy of any kind \\>1 month.\n\nPatient is between 18 to 75 years of age.\n\nPatient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent using a form approved by the Institutional Review Board/Ethics Committee (IRB/EC).\n\nExclusion Criteria:\n\nPatient has history of stroke.\n\nPatient has had ST Segment elevation myocardial infarction (MI); or previous cardiac surgery within 60 days prior to enrollment.\n\nPatient is pregnant or nursing.\n\nPatient has chronic New York Heart Association (NYHA) Class IV heart failure.\n\nPatient has limited life expectancy according to the investigator (less than one year).\n\nPatient has had a recent coronary artery bypass graft (CABG) (\\< 60 days) or percutaneous coronary intervention (PCI) (\\< 30 days).\n\nPatient is currently participating in an investigational drug or device study Patient is unable or unwilling to cooperate with the study procedures.\n\nPatient has a prosthetic mitral or aortic valve.\n\nPatient has mitral or aortic valvular heart disease requiring immediate surgical intervention.\n\nPatient has Left Ventricular EF \\< 15%.\n\nPatient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (\\> 3 months) outflow tract tachycardia.\n\nPatient has previously documented history of severe loss of kidney function or kidney failure.\n\nPatient has premature ventricular contractions (PVC) or VT induced cardiomyopathy expected to resolve with ablation and will not require an ICD.\n\nPatient has reversible cause of VT.'}, 'identificationModule': {'nctId': 'NCT02584595', 'acronym': 'EPIC', 'briefTitle': 'Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'An Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.', 'orgStudyIdInfo': {'id': 'SJM-CIP-10068'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ICD/CRT-D with NIPS or EP Study', 'type': 'DEVICE', 'description': 'ICD/CRT-D implanted patients are tested for inducible MMVT during electrophysiology (EP) Study or Non-Invasive Programmed Stimulation (NIPS) Study'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}