Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-04 @ 10:17 PM
Study NCT ID:
NCT03549468
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2018-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2018-05-25', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repolarization alternans, an ECG measure for susceptibility to VT/VF', 'timeFrame': 'during acute stimulation procedure', 'description': 'Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ischemic cardiomyopathy; neuromodulation; repolarization alternans'], 'conditions': ['Ischemic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Patients with ischemic cardiomyopathy (left ventricular ejection fraction \\<35%) and heart failure who already have an implantable device with an atrial lead (dual chamber defibrillator or biventricular defibrillator) will undergo sequentially 1. Sham low level tragus stimulation (LLTS) (5min), 2. Active LLTS at 5Hz (15min) and 20Hz (15min) and 3. Active LLTS group with atrial pacing at 100bpm at 5Hz (15min) and 20Hz (15min). The latter is required to examine the effect of LLTS on RA independent of heart rate. Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ischemic cardiomyopathy (LVEF \\<35%) and heart failure\n2. Implantable device with an atrial lead (dual chamber ICD or CRT-D)\n3. Sinus rhythm at the time of the study\n\nExclusion Criteria:\n\n1. Recent (\\<6 months) stroke or myocardial infarction\n2. Persistent atrial fibrillation\n3. Recurrent vaso-vagal syncopal episodes\n4. Unilateral or bilateral vagotomy\n5. Pregnancy or breast feeding\n6. Uncontrolled diabetes or hypertension\n7. Sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker)\n8. Bifascicular block or prolonged first degree block\n9. Hypotension due to autonomic dysfunction\n10. Inability or unwillingness to understand and/or sign informed consent'}, 'identificationModule': {'nctId': 'NCT03549468', 'acronym': 'ELEVATE-ICM', 'briefTitle': 'The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy', 'orgStudyIdInfo': {'id': '8672'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low level tragus stimulation (LLTS)', 'description': 'Patients with ischemic cardiomyopathy (left ventricular ejection fraction \\<35%) and heart failure who already have an implantable device with an atrial lead (dual chamber defibrillator or biventricular defibrillator) will undergo sequentially 1. Sham LLTS (5min), 2. Active LLTS at 5Hz (15min) and 20Hz (15min) and 3. Active LLTS group with atrial pacing at 100bpm at 5Hz (15min) and 20Hz (15min).', 'interventionNames': ['Device: Low level tragus stimulation']}], 'interventions': [{'name': 'Low level tragus stimulation', 'type': 'DEVICE', 'description': 'All patients will undergo sequentially: sham stimulation; LLTS (5Hz), LLTS (20Hz). The sequence will be repeated during atrial pacing at 100bpm', 'armGroupLabels': ['low level tragus stimulation (LLTS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}