Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation

NCT07891390 | Not Yet Recruiting

• 2 other identifiers: 26CH162ANSM
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

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.

Conditions

Atrial Fibrillation (AF); Cerebral Vascular Accident (CVA); Heart Failure; Myocardial Infarction (MI)

Keywords

cardiology; fibrillation; aortic valve

Outcome Measures

Primary Outcomes (1)

• 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.

  15 days

Secondary Outcomes (6)

• Cardiac autonomic activity

  3 months

• Blood Concentrations of Inflammatory Biomarkers

  3 months

• Inflammatory Biomarkers in Aortic Valve Tissue, Assessed by Immunohistochemistry

  3 months

• The quality of postoperative recovery

  3 months

• Adherence

  45 days

Study Arms (2)

patients with active tVNS

ACTIVE COMPARATOR

Other: tVNS "SHAM" session the conchae aurea of the left ear

patients with sham tVNS

SHAM COMPARATOR

Other: tVNS session on the left earlobe

Interventions

tVNS session on the left earlobe OTHER

\- 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

patients with sham tVNS

tVNS "SHAM" session the conchae aurea of the left ear OTHER

\- 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.

patients with active tVNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (3)

Chu Clermont-Ferrand

Clermont-Ferrand, France

Location

MAUREIRA Juan-Pablo

Nancy, France

Location

Centre Hospitalier Universitaire

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Heart Failure; Myocardial Infarction

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Myocardial Ischemia; Infarction; Ischemia; Necrosis

Central Study Contacts

David HUPIN, MD

CONTACT

0477828413; david.hupin@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The neurostimulator will be programmed to either the active stimulation mode or the sham placebo mode by a technician who is blinded to both the participant and the investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot, prospective, randomized, sham-controlled study as defined in the protocols of Stavrakis et al (2017, 2020). Patients will be randomized (2:1) into an experimental NSVt group, corresponding to an active NSVt applied between 1h and 2h per day, and a sham/control group. The active NSVt will be performed using a TENS and an auricular electrode placed in the aurea concha of the ear, which is innervated by the auricular branch of the vagus nerve. The sham NSVt group will be performed with the same TENS device and an electrode placed at the ear lobe. In both groups, the stimulation will be delivered at a frequency of 20 Hz and at a pulse of 200 ms. with a stimulation amplitude individually titrated so as to reach 1 mA below the level of unpleasant sensation of 1 to 2 hours per day depending on the tolerance and possibilities of the patient. The duration of the NSVt will depend on the planning time of the surgery (between 15 and 45 pre-operative days). Randomization will be ca

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): January 31, 2027
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)