Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB

NCT07824492 | Not Yet Recruiting DMC

• 1 other identifier: 2025575
• Study Type: interventional
• Target: 410
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation (AF); OPCABG

Outcome Measures

Primary Outcomes (1)

• Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB

  The proportion of participants who develop new-onset postoperative atrial fibrillation (POAF) after off-pump coronary artery bypass grafting. POAF is defined as an episode of atrial fibrillation lasting at least 30 seconds, detected by continuous electrocardiographic monitoring, Holter monitoring, or telemetry. Events will be adjudicated by outcome assessors blinded to treatment allocation.

  From the end of surgery through postoperative day 7

Secondary Outcomes (5)

• Duration of Postoperative Atrial Fibrillation

  From the end of surgery through postoperative day 7

• Change in Circulating Inflammatory Markers

  Baseline and postoperative 24, 72 and 120 hours

• Heart Rate Variability

  From the end of surgery through postoperative day 7

• Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation

  Through postoperative day 7

• Initiation of Anticoagulation for Postoperative Atrial Fibrillation

  Through postoperative day 7

Study Arms (2)

taVNS Plus Standard Care

EXPERIMENTAL

Participants assigned to this arm will receive perioperative transcutaneous auricular vagus nerve stimulation (taVNS) in addition to standard perioperative care for off-pump coronary artery bypass grafting.

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Standard Care

NO INTERVENTION

Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS.

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

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.

taVNS Plus Standard Care

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Scheduled to undergo elective off-pump coronary artery bypass grafting (OPCAB) for coronary artery disease with multivessel coronary artery disease.
• Sinus rhythm on the preoperative baseline electrocardiogram, with no history of atrial fibrillation or other clinically significant arrhythmias.
• Able and willing to provide written informed consent and comply with the study intervention and follow-up procedures.
• Expected postoperative hospital stay of at least 7 days to allow postoperative atrial fibrillation monitoring.

You may not qualify if:

• History of atrial fibrillation or other arrhythmias requiring antiarrhythmic therapy.
• Emergency OPCAB surgery or intraoperative conversion to on-pump coronary artery bypass grafting.
• Concomitant cardiac surgery, such as valve surgery, or hybrid cardiac procedures.
• Vagus nerve-related disorders, epilepsy, active ear infection, or implanted electrical devices such as a pacemaker or implantable cardioverter-defibrillator.
• Severe comorbidities, including severe renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73 m²), active malignancy, current immunosuppressive therapy, or chronic inflammatory disease.
• Inability to tolerate auricular stimulation, including significant skin allergy or intolerance, or anticipated poor adherence to the study procedures.
• Expected survival of less than 12 months or inability to complete follow-up.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yanjun Sun, M.D.

CONTACT

+8613918484784; syj11595@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication of the primary study results and remaining available for 5 years.
• Access Criteria: Deidentified individual participant data and the specified supporting information will be made available to qualified researchers who submit a methodologically sound proposal for scientifically valid analyses. Requests will be reviewed by the principal investigator and study team. Access will be granted subject to applicable institutional, ethical, and privacy requirements and, where appropriate, completion of a data-use agreement. Data will be provided only for the purposes approved in the request.