Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib

NCT04514757 | Completed FDA Device

• 1 other identifier: 20-001636
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

Patients undergoing cardiac surgery are at high risk of developing atrial fibrillation (AF), with estimated rates of 30-50% and occurs at approximately 2-4 days after surgery. The autonomic nervous system is known to play a key role in AF. Animal studies have indicated that duration and inducibility of AF can be decreased with intermittent vagus nerve stimulation (VNS). In humans, literature suggests that transcutaneous (tragus) VNS (tVNS) can serve as a potentially non-invasive therapy for treatment of post-operative AF (POAF) by reducing inflammation and increasing atrial refractory period. The purpose of this study is to determine the value of tVNS in reducing the burden of POAF and days of hospitalization after cardiac surgery.

Conditions

Atrial Fibrillation

Keywords

post-operative atrial fibrillation; transcutaneous (tragus) vagal nerve stimulation; outcomes

Outcome Measures

Primary Outcomes (1)

• Atrial Fibrillation

  Incidence of post-operative atrial fibrillation for postoperative day 0-5 (postop day 0 is the day of the surgery and is the first day of the time frame and postoperative day 5 is the 6th day).

  6 days

Secondary Outcomes (7)

• Days of hospitalization

  Postop day 0 until discharge from the hospital, an average of 1 week.

• Inflammatory markers

  Within 12 hours of arrival to the ICU after surgery and on postop day 3 (2 days)

• Sympathetic neural markers

  Postop day 3 (1 day)

• Pain assessment

  6 days

• Narcotic Usage

  6 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

Active tVNS (Parasym device, Parasym Health, Inc, London, UK) will be performed with a clip attached to ear at 20 Hz, 250ms at a current just below discomfort threshold for one hour twice a day, starting on post-day 0. Stimulation will continue until 5 days post-operatively or discharge.

Device: active tVNS

Control Group

SHAM COMPARATOR

Sham tVNS will be performed by attaching the Parasym device to the ear and setting output to 0. Stimulation will continue until 5 days post-operatively or discharge.

Device: sham tVNS

Interventions

active tVNS DEVICE

20 Hz, 250ms at a current just below discomfort threshold for one hour twice a day, starting on post-day 0. Stimulation will continue until 5 days post-operatively or discharge.

Intervention Group

sham tVNS DEVICE

Current set a 0 mA, starting on post-op day 0. Stimulation will continue until 5 days post-operatively or discharge.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons.
• Age ≥ 18 years.
• Sinus rhythm at baseline.
• Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study

You may not qualify if:

• Emergent surgery
• Anticipated amiodarone use
• Patients with permanent or persistent atrial fibrillation
• Planned concomitant atrial Maze procedure
• Complex congenital heart disease
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
• Left ventricular assist device or status post orthotopic heart or lung transplantation
• Unable or unwilling to comply with protocol requirements.
• Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
• Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker.
• Complete heart block or trifascicular block without an implantable pacemaker
• Recurrent vasovagal syncope
• Unilateral or bilateral vagotomy
• Chronic amiodarone use

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Oklahoma: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (8)

• Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010.

  PMID: 11747385 BACKGROUND

• Aranki SF, Shaw DP, Adams DH, Rizzo RJ, Couper GS, VanderVliet M, Collins JJ Jr, Cohn LH, Burstin HR. Predictors of atrial fibrillation after coronary artery surgery. Current trends and impact on hospital resources. Circulation. 1996 Aug 1;94(3):390-7. doi: 10.1161/01.cir.94.3.390.

  PMID: 8759081 BACKGROUND

• Chen PS, Chen LS, Fishbein MC, Lin SF, Nattel S. Role of the autonomic nervous system in atrial fibrillation: pathophysiology and therapy. Circ Res. 2014 Apr 25;114(9):1500-15. doi: 10.1161/CIRCRESAHA.114.303772.

  PMID: 24763467 BACKGROUND

• Salavatian S, Beaumont E, Longpre JP, Armour JA, Vinet A, Jacquemet V, Shivkumar K, Ardell JL. Vagal stimulation targets select populations of intrinsic cardiac neurons to control neurally induced atrial fibrillation. Am J Physiol Heart Circ Physiol. 2016 Nov 1;311(5):H1311-H1320. doi: 10.1152/ajpheart.00443.2016. Epub 2016 Sep 2.

  PMID: 27591222 BACKGROUND

• Stavrakis S, Humphrey MB, Scherlag B, Iftikhar O, Parwani P, Abbas M, Filiberti A, Fleming C, Hu Y, Garabelli P, McUnu A, Peyton M, Po SS. Low-Level Vagus Nerve Stimulation Suppresses Post-Operative Atrial Fibrillation and Inflammation: A Randomized Study. JACC Clin Electrophysiol. 2017 Sep;3(9):929-938. doi: 10.1016/j.jacep.2017.02.019. Epub 2017 May 30.

  PMID: 29759717 BACKGROUND

• Stavrakis S, Humphrey MB, Scherlag BJ, Hu Y, Jackman WM, Nakagawa H, Lockwood D, Lazzara R, Po SS. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol. 2015 Mar 10;65(9):867-75. doi: 10.1016/j.jacc.2014.12.026.

  PMID: 25744003 BACKGROUND

• Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. JACC Clin Electrophysiol. 2020 Mar;6(3):282-291. doi: 10.1016/j.jacep.2019.11.008. Epub 2020 Jan 29.

  PMID: 32192678 BACKGROUND

• Andreas M, Arzl P, Mitterbauer A, Ballarini NM, Kainz FM, Kocher A, Laufer G, Wolzt M. Electrical Stimulation of the Greater Auricular Nerve to Reduce Postoperative Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2019 Oct;12(10):e007711. doi: 10.1161/CIRCEP.119.007711. Epub 2019 Oct 10.

  PMID: 31597476 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Ho, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Marmar Vaseghi, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Stavros Stavrakis, MD, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 17, 2020
• Study Start: September 20, 2021
• Primary Completion: March 25, 2024
• Study Completion: April 25, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)