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

Primary Purpose

Ischemic Cardiomyopathy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low level tragus stimulation

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy focused on measuring ischemic cardiomyopathy; neuromodulation; repolarization alternans

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

low level tragus stimulation (LLTS)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03549468

First Posted

May 25, 2018

Last Updated

May 25, 2022

Sponsor

University of Oklahoma

Collaborators

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03549468

Brief Title

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

Acronym

ELEVATE-ICM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

May 25, 2018 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

Collaborators

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Cardiomyopathy

Keywords

ischemic cardiomyopathy; neuromodulation; repolarization alternans

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

low level tragus stimulation (LLTS)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Low level tragus stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Repolarization alternans, an ECG measure for susceptibility to VT/VF

Description

Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software

Time Frame

during acute stimulation procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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