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NCT Number: NCT07824492

Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases OPCABG Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: From the end of surgery through postoperative day 7

    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.

Secondary outcomes

  1. Duration of Postoperative Atrial Fibrillation

    Time frame: From the end of surgery through postoperative day 7

    Total duration of postoperative atrial fibrillation episodes detected by continuous electrocardiographic monitoring during the first 7 days after surgery.

  2. Change in Circulating Inflammatory Markers

    Time frame: Baseline and postoperative 24, 72 and 120 hours

    Changes in serum interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP) levels will be assessed to evaluate the perioperative inflammatory response.

  3. Heart Rate Variability

    Time frame: From the end of surgery through postoperative day 7

    Heart rate variability will be assessed using Holter monitoring, including SDNN and RMSSD as measures of autonomic function.

  4. Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation

    Time frame: Through postoperative day 7

    Proportion of participants requiring antiarrhythmic medication for treatment of postoperative atrial fibrillation, including drugs such as amiodarone.

  5. Initiation of Anticoagulation for Postoperative Atrial Fibrillation

    Time frame: Through postoperative day 7

    Proportion of participants in whom anticoagulant therapy is initiated because of postoperative atrial fibrillation.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanjun Sun, M.D.

CONTACT

[email protected]

+8613918484784

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Acronym: TRAP-AF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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