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

University of Oklahoma26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Cardiomyopathy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: during acute stimulation procedure