tVNS for Atrial Fibrillation
(STOP_AF Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMarmar Vaseghi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if using electrical pulses on a nerve in the ear can prevent irregular heartbeats in patients after heart surgery. The treatment aims to reduce inflammation and help the heart beat regularly.

Research Team

Stavros Stavrakis, MD, PhD

Principal Investigator

University of Oklahoma

Jonathan Ho, MD

Principal Investigator

University of California, Los Angeles

Marmar Vaseghi, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for adults over 18 who are scheduled for cardiac surgery and currently have a normal heart rhythm. They must be willing to follow the study procedures. People with certain heart conditions, pregnant women, those on chronic amiodarone therapy or with complex congenital heart disease, among others, cannot participate.

Inclusion Criteria

I am 18 years old or older.

Your heart is beating normally at the start of the study.

I am scheduled for major heart or blood vessel surgery.

See 1 more

Exclusion Criteria

I have had multiple fainting spells.

I have a diagnosed heart rhythm disorder.

I have ongoing or permanent atrial fibrillation.

See 11 more

Treatment Details

Interventions

Transcutaneous (Tragus) Vagal Nerve Stimulation (Behavioural Intervention)

Trial OverviewThe trial is testing if non-invasive transcutaneous vagal nerve stimulation (tVNS) can reduce the occurrence of atrial fibrillation after cardiac surgery and shorten hospital stays. Participants will receive either active tVNS or a sham (fake) treatment as a comparison.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Control GroupPlacebo Group1 Intervention

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.