An interventional study of tVNS session on the left earlobe and tVNS "SHAM" session the conchae aurea of the left ear in Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA) and Heart Failure, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Prevention
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 64 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
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Exclusion Criteria:
Other: tVNS "SHAM" session the conchae aurea of the left ear
Other: tVNS session on the left earlobe
\- 15-45 days before the surgery, 1h-2h daily tVNS session is delivered on the conchae aurea of the left ear, in resting condition. Parameters of tVNS: frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level
\- 15-45 days before the surgery, 1h-2h daily tVNS session is delivered on the left earlobe, in resting condition. Parameters of tVNS: frequency 20Hz, impulsion 200ms, amplitude 1mA below the unpleasant sensation level.
Change From Baseline in RMSSD of Heart Rate Variability After the Last tVNS Session
RMSSD (ms), a measure of parasympathetic cardiac activity, will be measured from HRV recordings (Holter 24h). Recordings will be made before the first session and after the last session of transcutaneous auricular vagus nerve stimulation (tVNS), delivered for 1 to 2 hours per day during the preoperative period. A higher RMSSD indicates greater parasympathetic activity. The outcome is the change in RMSSD from baseline to after the last session.
Time frame: 15 days
Cardiac autonomic activity
Cardiac autonomic activity, as measured by HRV, will be assessed postoperatively using the RMSSD parameter (ms).
Time frame: 3 months
Blood Concentrations of Inflammatory Biomarkers
Inflammatory activity will be assessed from blood concentrations of C-reactive protein (CRP, mg/L), fibrinogen (g/L) and ferritin (µg/L), measured in routine care blood samples. One blood tube per participant will be stored for retrospective complementary analyses of cytokines (TNF-α, IL-6, IL-1, IL-10, IL-17; pg/mL).
Time frame: 3 months
Inflammatory Biomarkers in Aortic Valve Tissue, Assessed by Immunohistochemistry
Inflammatory activity will be assessed using inflammatory biomarkers in aortic valve tissue, analyzed by immunohistochemistry. Results are reported as the quantification of marker-positive staining
Time frame: 3 months
The quality of postoperative recovery
The quality of postoperative recovery will be assessed using the Quality-Of-Recovery-15 (QoR-15) questionnaire (scores range from 0 to 150; higher scores indicate better recovery)
Time frame: 3 months
Adherence
Total duration of transcutaneous auricular vagus nerve stimulation (tVNS) actually delivered, calculated as the total of the daily stimulation durations over all days on which stimulation was completed, as recorded by the participant in a tracking log. A single value is reported per participant, expressed in minutes.
Time frame: 45 days
The Feasibility indicators
Feasibility indicators will include the eligibility rate, the inclusion rate, the refusal rate, and the 3-month follow-up rate. Satisfaction will be assessed using an overall satisfaction scale (a 1-to-5 Likert scale).
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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