Auricular vagal neuromodulation therapy (AVNT) with Nurosym for preventing postoperative atrial fibrillation, decreasing inflammatory responses, and improving patient recovery following CABG – a randomized controlled trial
Postoperative atrial fibrillation, following cardiac surgery, pain, stress
Current interventions as of 11/03/2026: Assignment to each of the two parallel arms will be performed based on a stratified block randomization scheme, with a stratum assigned to each sex (male/female), and another stratum assigned to preoperative treatment with beta-blockers (yes/no), and a small block size (eg. block size = 4). The randomization scheme will be generated in R (eg. “blockrand” package) and uploaded in REDCap. The assignment to experimental/control arms will be performed automatically for each new participant entry in REDcap. The randomization scheme will be concealed to the REDCap data entry user. The intervention consists in AVNT with Nurosym device adjunct to standard of care : 1 h preoperatively, 1h intraoperatively, and 7h daily starting from their arrival in ICU or intermediate care (the day of surgery, day 0) and until postoperative day 4, with even exposure between the left and right ear. The comparator will be sham (null current delivered by the electrode attached to tragus) adjunct to standard of care. _____ Previous interventions: Assignment to each of the two parallel arms will be performed based on a stratified block randomization scheme, with a stratum assigned to each sex (male/female), and a small block size (block size = 4). The randomization scheme will be generated in R (eg. “blockrand” package) and uploaded in REDCap. The assignment to experimental/control arms will be performed automatically for each new participant entry in REDcap. The randomization scheme will be concealed to the REDCap data entry user. The intervention consists in AVNT with Nurosym device adjunct to standard of care : 1 h preoperatively, 1h intraoperatively, and 7h daily starting from their arrival in ICU or intermediate care (the day of surgery, day 0) and until postoperative day 4, with even exposure between the left and right ear. The comparator will be sham (null current delivered by the electrode attached to tragus) adjunct to standard of care.
1. Age 18 years old or older 2. Undergoing elective on-pump isolated CABG
1. History of atrial fibrillation or atrial flutter before CABG 2. Preoperative sinus node dysfunction, atrioventricular block, severe bradycardia, heart valve disease 3. Undergoing CABG combined with another type of surgery 4. Permanent pacemaker before surgery 5. Off-pump CABG 6. Undergoing urgent or emergency surgery 7. Contraindications and limitations of the Nurosym device: - Cervical vagotomy - Permanent metallic/electronic device (e.g., cochlear implants) or jewellery in close proximity to ear tragus - Pregnant women - Cerebral shunts - Invasive vagus nerve stimulators - Non-active metal implants potentially interacting with the nervous system (e.g., metallic spinal implants) - Lesions (e.g., cracked skin or wounds) on the tragus 8. Vulnerable subjects (e.g., prisoners) 9. Inability of the subject to consent or to follow the procedures of the investigation (e.g., due to language problems, psychological disorders, etc.)