Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT01448005
Status:
TERMINATED
Last Update Posted:
2017-12-06
First Post:
2011-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LifeVest Post-CABG Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2011-10-05', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients who experience sudden cardiac death', 'timeFrame': 'three months'}], 'secondaryOutcomes': [{'measure': 'number of patients who experience inappropriate shocks', 'timeFrame': 'three months'}, {'measure': 'hours per day of wearable defibrillator use', 'timeFrame': 'three months'}, {'measure': 'number of patients who experience sudden cardiac arrest', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Grafting', 'Resuscitation', 'Sudden Cardiac Death', 'Ventricular Dysfunction'], 'conditions': ['Sudden Cardiac Death', 'Ventricular Fibrillation', 'Ventricular Tachycardia', 'Ventricular Dysfunction', 'Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have undergone CABG surgery during current hospitalization and have an ejection fraction ≤ 35% following the surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have undergone CABG surgery during current hospitalization\n* Patients who have an ejection fraction ≤ 35% following the surgery.\n* Patients who have dilated cardiomyopathy or prior myocardial infarction.\n* Patients who are prescribed a wearable defibrillator following surgery.\n* Patient who are at least 18 years old.\n\nExclusion Criteria:\n\n* Patients who have an active ICD.\n* Patients who have an active unipolar pacemaker.\n* Patients having a chest circumference over 56 inches or under 26 inches.\n* Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.\n* Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.\n* Patients participating in another clinical study with mortality as the primary endpoint.\n* Patients unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, dextrocardia, etc.).\n* Patients who have decided to forgo resuscitation.'}, 'identificationModule': {'nctId': 'NCT01448005', 'briefTitle': 'LifeVest Post-CABG Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery', 'orgStudyIdInfo': {'id': '90D0107'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'wearable defibrillator use', 'description': 'subjects will use a wearable defibrillator', 'interventionNames': ['Device: wearable defibrillator (LifeVest)']}], 'interventions': [{'name': 'wearable defibrillator (LifeVest)', 'type': 'DEVICE', 'otherNames': ['LifeVest', 'wearable cardioverter defibrillator', 'wearable automatic external defibrillator'], 'description': 'A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.', 'armGroupLabels': ['wearable defibrillator use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Heart and Vascular Institute', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Saint Joseph's Health System, Inc.", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '20912', 'city': 'Takoma Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'Washington Adventist Hospital', 'geoPoint': {'lat': 38.97789, 'lon': -77.00748}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Heart Institute, St. Luke's Episcopal Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Chippenham Johnston-Willis Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Steven J Szymkiewicz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zoll Medical Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}