The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Subjects With Ischemic CardioMyopathy
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 6/10/2018 |
| Start Date: | May 25, 2018 |
| End Date: | August 2019 |
The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy
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.
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.
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
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Stavros Stavrakis, MD, PhD
Phone: 405-271-2229
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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