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The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy (ELEVATE-ICM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549468
Recruitment Status : Suspended (Due to COVID-19)
First Posted : June 8, 2018
Last Update Posted : April 9, 2020
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ischemic Cardiomyopathy Device: Low level tragus stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: low level tragus stimulation (LLTS)
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).
Device: Low level tragus stimulation
All patients will undergo sequentially: sham stimulation; LLTS (5Hz), LLTS (20Hz). The sequence will be repeated during atrial pacing at 100bpm




Primary Outcome Measures :
  1. Repolarization alternans, an ECG measure for susceptibility to VT/VF [ Time Frame: during acute stimulation procedure ]
    Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ischemic cardiomyopathy (LVEF <35%) and heart failure
  2. Implantable device with an atrial lead (dual chamber ICD or CRT-D)
  3. Sinus rhythm at the time of the study

Exclusion Criteria:

  1. Recent (<6 months) stroke or myocardial infarction
  2. Persistent atrial fibrillation
  3. Recurrent vaso-vagal syncopal episodes
  4. Unilateral or bilateral vagotomy
  5. Pregnancy or breast feeding
  6. Uncontrolled diabetes or hypertension
  7. Sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker)
  8. Bifascicular block or prolonged first degree block
  9. Hypotension due to autonomic dysfunction
  10. Inability or unwillingness to understand and/or sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549468


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Massachusetts General Hospital
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03549468    
Other Study ID Numbers: 8672
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Oklahoma:
ischemic cardiomyopathy; neuromodulation; repolarization alternans
Additional relevant MeSH terms:
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Cardiomyopathies
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases