The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy Substrate of Subjects With Ischemic CardioMyopathy (ELEVATE-ICM)

May 25, 2022 updated by: University of Oklahoma

The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during acute stimulation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8672

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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