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

• Sponsor: University of Oklahoma (Other)
• Overall Status: Completed
• CT.gov ID: NCT03549468
• Collaborator: Massachusetts General Hospital (Other)
• Enrollment: 26
• Location: 1
• Arm: 1
• Actual Duration (Months): 46.2
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Cardiomyopathy	Device: Low level tragus stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy
• Actual Study Start Date: May 25, 2018
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Mar 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of Oklahoma
• Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT03549468
• Other Study ID Numbers: 8672
• First Posted: Jun 8, 2018
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by University of Oklahoma: ischemic cardiomyopathy; neuromodulation; repolarization alternans
• Additional relevant MeSH terms: Cardiomyopathies; Ischemia

Study Results

No Results Posted as of May 26, 2022