Ear nerve stimulation before heart valve surgery in adults
Tests ear-based nerve stimulation before aortic valve surgery in adults.
Plain-language title generated from the registry record
Registry title: Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
Key facts
- Where
- Clermont-Ferrand, Nancy, and Saint-Etienne, FranceSee the 3 sites
Where in France
- CHU Clermont-FerrandClermont-Ferrand, FranceNo longer taking part
- MAUREIRA Juan-PabloNancy, FranceNo longer taking part
- Centre Hospitalier UniversitaireSaint-Etienne, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Saint Etienne
- Trial code
- NCT07891390
- Record updated
- 23 October 2026
- Original description
Post-operative atrial fibrillation (POAF) is a frequent complication of surgical aortic valve replacement, affecting 38 to 63% of patients, and increasing risks of stroke, heart failure, and long-term mortality. By intervening upstream of surgical stress, transcutaneous vagal nerve stimulation (tVNS) could act as an autonomic and anti-inflammatory preconditioning, stabilizing sympathovagal balance, reducing POAF susceptibility and post-operative outcomes. This pilot study evaluates the feasibility, tolerability, and biological activity of a preoperative tVNS protocol versus sham (1-2 hours/day), with ΔRMSSD, a non-invasive marker of parasympathetic modulation as the primary endpoint, inflammatory biomarkers, postoperative recovery, and cardiovascular events up to 3 months as secondary outcomes. This step is essential to identify a preoperative strategy that is practicable, well-tolerated, and capable of inducing measurable parasympathetic modulation prior to surgery and the prevention of POAF.Read full original descriptionShow less
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation Prior to Aortic Valve Surgery VAGASTIMA - PILOT: a Multicenter, Randomized Study
Post-operative atrial fibrillation (POAF) is a frequent complication of surgical aortic valve replacement, affecting 38 to 63% of patients, and increasing risks of stroke, heart failure, and long-term mortality. By intervening upstream of surgical stress, transcutaneous vagal nerve stimulation (tVNS) could act as an autonomic and anti-inflammatory preconditioning, stabilizing sympathovagal balance, reducing POAF susceptibility and post-operative outcomes. This pilot study evaluates the feasibility, tolerability, and biological activity of a preoperative tVNS protocol versus sham (1-2 hours/day), with ΔRMSSD, a non-invasive marker of parasympathetic modulation as the primary endpoint, inflammatory biomarkers, postoperative recovery, and cardiovascular events up to 3 months as secondary outcomes. This step is essential to identify a preoperative strategy that is practicable, well-tolerated, and capable of inducing measurable parasympathetic modulation prior to surgery and the prevention of POAF.
Inclusion: Patients enrolled in or eligible for a social security program; Patients who have received informed information about the study and have co-signed, with the investigator, a consent form to participate in the study; Patients undergoing aortic valve replacement surgery, including associated coronary artery bypass grafting (CABG); Patient whose surgery is scheduled at least 2 weeks after the initial consultation with the surgeon (so that NSVt can be monitored for at least 15 days); Patient with a regular sinus rhythm.
Exclusion: Pre-existing FA prior to surgery,; Recurrent episodes of vasovagal syncope; Unilateral or bilateral vagotomy; Dermatological issues in the area where the stimulation electrode is placed; Pregnancy or breastfeeding; Patient under legal guardianship (court-ordered protection, conservatorship, guardianship).