Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulation
DeviceTranscutaneous 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.
Treatment groups
410 Participants
are divided into 2 treatment groupsGroup A: taVNS Plus Standard CareExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
From the end of surgery through postoperative day 7Secondary outcomes
1
Duration of Postoperative Atrial Fibrillation
Total duration of postoperative atrial fibrillation episodes detected by continuous electrocardiographic monitoring during the first 7 days after surgery.
Time frame
From the end of surgery through postoperative day 72
Change in Circulating Inflammatory Markers
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.
Time frame
Baseline and postoperative 24, 72 and 120 hours3
Heart Rate Variability
Heart rate variability will be assessed using Holter monitoring, including SDNN and RMSSD as measures of autonomic function.
Time frame
From the end of surgery through postoperative day 74
Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation
Proportion of participants requiring antiarrhythmic medication for treatment of postoperative atrial fibrillation, including drugs such as amiodarone.
Time frame
Through postoperative day 7Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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