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

University of Oklahoma (OU)

Status: Completed

Conditions: Ischemic Cardiomyopathy

Treatments: Device: Low level tragus stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03549468

8672

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

low level tragus stimulation (LLTS)

Experimental group

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).

Treatment:

Device: Low level tragus stimulation