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NOT YET RECRUITING
NCT07824492
NA

Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass surgery and may be associated with prolonged hospitalization and adverse cardiovascular outcomes. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that delivers mild electrical stimulation to the ear and may help regulate autonomic and inflammatory responses. This randomized controlled trial will evaluate whether perioperative taVNS can reduce the incidence of POAF in adults undergoing elective off-pump coronary artery bypass grafting (OPCAB). Participants will be randomly assigned in a 1:1 ratio to receive either taVNS in addition to standard perioperative care or standard perioperative care alone. The primary outcome is the incidence of new-onset atrial fibrillation within 7 days after surgery. Secondary outcomes will include atrial fibrillation burden, inflammatory markers, heart rate variability, use of antiarrhythmic and anticoagulant medications, safety, length of hospital stay, and major adverse cardiovascular events during follow-up.

Official title: A Single-Center, Randomized, Open-Label Study of Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2026-10-01

Completion Date

2027-10

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

Transcutaneous auricular vagus nerve stimulation (taVNS) will be delivered using the taVNS device. Stimulation will be applied to the left auricular region targeting the auricular branch of the vagus nerve. The stimulation frequency will be 20 Hz with a pulse width of approximately 200 μs. Stimulation intensity will be gradually increased from zero to the highest level that is comfortably tolerated without pain. Participants will receive two stimulation sessions per day, separated by at least 4-6 hours, beginning 1 days before surgery and continuing through postoperative day 7. Each session will last 60 minutes. Standard perioperative care for off-pump coronary artery bypass grafting will be provided concurrently.