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

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Key information

Conditions

Ischemic Cardiomyopathy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low level tragus stimulation

Device

All patients will undergo sequentially: sham stimulation; LLTS (5Hz), LLTS (20Hz). The sequence will be repeated during atrial pacing at 100bpm

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

Massachusetts General Hospital

Registry information

Official study title

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

Acronym: ELEVATE-ICM

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2022
First posted: Jun 8, 2018
Registry last updated: May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed