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

Ischemic Cardiomyopathy Clinical Trial

— ELEVATE-ICM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549468
• Other study ID #: 8672
• Status: Completed
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: May 2022
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy

Intervention

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

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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