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

Not Applicable

Completed

• Conditions: Ischemic Cardiomyopathy
• Interventions: Device: Low level tragus stimulation

• Registration Number: NCT03549468
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-25
• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-08
• Primary Completion: 2021-06-30
• Study Completion: 2022-03-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
low level tragus stimulation (LLTS)	Low level tragus stimulation	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).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States