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Behavioural Intervention

tVNS for Atrial Fibrillation (STOP_AF Trial)

N/A

Recruiting

Led By Stavros Stavrakis, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years.

Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 12 hours of arrival to the icu after surgery and on postop day 3 (2 days)

Awards & highlights

STOP_AF Trial Summary

This trial is testing whether stimulating the vagus nerve non-invasively can help reduce atrial fibrillation (AF) after cardiac surgery. AF is a common complication after surgery, and can prolong hospital stays. This trial will test whether tVNS can help reduce the burden of AF and days of hospitalization.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

While specific side effects of tVNS are not detailed here, similar treatments may cause local discomfort at the site of stimulation, headache, voice changes or hoarseness.

STOP_AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for major heart or blood vessel surgery.

STOP_AF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 12 hours of arrival to the icu after surgery and on postop day 3 (2 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 12 hours of arrival to the icu after surgery and on postop day 3 (2 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 12 hours of arrival to the icu after surgery and on postop day 3 (2 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Atrial Fibrillation

Secondary outcome measures

Days of hospitalization

Duration of post-op atrial fibrillation

Heart rate during atrial fibrillation

+4 more

STOP_AF Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

active tVNS

2019

N/A

~20

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,264,421 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

1 Patients Enrolled for Atrial Fibrillation

University of OklahomaOTHER

455 Previous Clinical Trials

97,347 Total Patients Enrolled

13 Trials studying Atrial Fibrillation

2,412 Patients Enrolled for Atrial Fibrillation

Stavros Stavrakis, MD, PhDPrincipal InvestigatorUniversity of Oklahoma

4 Previous Clinical Trials

563 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

90 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being sought for this trial?

"As indicated on clinicaltrials.gov, this experiment is currently searching for volunteers; the original posting date was September 20th 2021 and the listing was last changed to December 21st of that same year."

Answered by AI

Are geriatric patients eligible to join this research endeavor?

"For inclusion in this trial, participants must be aged 18 and over but must not have surpassed their 80th birthday."

Answered by AI

Are there any eligibility criteria that would permit me to join this experiment?

"This clinical study is accepting 266 participants who have atrial fibrillation and are aged between 18 to 80 years."

Answered by AI

What is the scope of participation for this research experiment?

"Indeed, according to the information on clinicaltrials.gov, this medical study is actively recruiting participants since its posting date of September 20th 2021 and most recent update of December 21st 2021. There are 266 patients needed from two different sites for enrollment in this trial."

Answered by AI

Recent research and studies

Annals of Internal MedicineJournal

Atrial Fibrillation After Cardiac Surgery

Maisel, William H., James D. Rawn, and William G. Stevenson. 2001. “Atrial Fibrillation After Cardiac Surgery”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-135-12-200112180-00010.

Circulation: Arrhythmia and ElectrophysiologyJournal

Electrical Stimulation of the Greater Auricular Nerve to Reduce Postoperative Atrial Fibrillation

Andreas, Martin, Philipp Arzl, Andreas Mitterbauer, Nicolas M. Ballarini, Frieda-Maria Kainz, Alfred Kocher, Guenther Laufer, and Michael Wolzt. 2019. “Electrical Stimulation of the Greater Auricular Nerve to Reduce Postoperative Atrial Fibrillation”. Circulation: Arrhythmia and Electrophysiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circep.119.007711.

CirculationJournal

Predictors of Atrial Fibrillation After Coronary Artery Surgery

Aranki, Sary F., David P. Shaw, David H. Adams, Robert J. Rizzo, Gregory S. Couper, Martha VanderVliet, John J. Collins, Lawrence H. Cohn, and Helen R. Burstin. 1996. “Predictors of Atrial Fibrillation After Coronary Artery Surgery”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.cir.94.3.390.

JACC: Clinical ElectrophysiologyJournal