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Life sciences · Interventional Study
ClinicalTrials.gov · October 23, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07891390). This is a study registration, not published results. Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 64 participants (ESTIMATED). Conditions: Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA), Heart Failure, Myocardial Infarction (MI). Interventions: OTHER: tVNS session on the left earlobe; OTHER: tVNS "SHAM" session the conchae aurea of the left ear. Primary outcome measures: Change From Baseline in RMSSD of Heart Rate Variability After the Last tVNS Session , 15 days. Brief summary: 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.