The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy

Study Overview
=================
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.

Official Title
-----------------
The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy

Conditions
-----------------
Ischemic Cardiomyopathy

Intervention / Treatment
-----------------
* Device: Low level tragus stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic cardiomyopathy (LVEF <35%) and heart failure Implantable device with an atrial lead (dual chamber ICD or CRT-D) Sinus rhythm at the time of the study Exclusion Criteria: Recent (<6 months) stroke or myocardial infarction Persistent atrial fibrillation Recurrent vaso-vagal syncopal episodes Unilateral or bilateral vagotomy Pregnancy or breast feeding Uncontrolled diabetes or hypertension Sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker) Bifascicular block or prolonged first degree block Hypotension due to autonomic dysfunction Inability or unwillingness to understand and/or sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low level tragus stimulation (LLTS)<br>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<br>* All patients will undergo sequentially: sham stimulation; LLTS (5Hz), LLTS (20Hz). The sequence will be repeated during atrial pacing at 100bpm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repolarization alternans, an ECG measure for susceptibility to VT/VF | Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software | during acute stimulation procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemic cardiomyopathy; neuromodulation; repolarization alternans