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

NCT03549468 | Completed DMC FDA Device

• 1 other identifier: 8672
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy

Keywords

ischemic cardiomyopathy; neuromodulation; repolarization alternans

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

low level tragus stimulation (LLTS)

EXPERIMENTAL

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

Interventions

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

low level tragus stimulation (LLTS)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: May 25, 2018
• Primary Completion: June 30, 2021
• Study Completion: March 30, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

US (1)