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Neuromodulation to improve patient recovery after coronary artery bypass grafting

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18258415
Enrollment
110
Registered
2025-11-13
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative atrial fibrillation, following cardiac surgery, pain, stress Circulatory System

Interventions

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/fema

Sponsors

Hôpitaux Universitaires de Genève (HUG)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years old or older 2. Undergoing elective on-pump isolated CABG

Exclusion criteria

Exclusion criteria: 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.)

Countries

Switzerland

Contacts

Public ContactDaniela Dumitriu LaGrange
Daniela.DumitriuLagrange@unige.ch0041795539870

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026