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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03549468

Acronym

ELEVATE-ICM

Enrollment

Registered

2018-06-08

Start date

2018-05-25

Completion date

2022-03-30

Last updated

2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Cardiomyopathy

Keywords

ischemic cardiomyopathy; neuromodulation; repolarization alternans

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.

Interventions

DEVICELow level tragus stimulation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026