Atrial Fibrillation (AF)VAGASTIMA-PILTNCT07891390
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
A study testing tVNS session on the left earlobe in people with Atrial Fibrillation (AF) and Cerebral Vascular Accident (CVA), run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA), Heart Failure
- What is being tested?
- tVNS session on the left earlobe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 3 sitesFrance
- Study dates
- 31 Jan 2027to 30 Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Chu Clermont-Ferrand
Clermont-Ferrand
Nicolas D'OSTREVY, PhD, 04 73 75 07 50 ext. 33, ndostrevy@chu-clermontferrand.fr
Nicolas D'OSTREVY, PhD
MAUREIRA Juan-Pablo
Nancy
MAUREIRA MAUREIRA, PHD
Juan-Pablo MAUREIRA, PHD
Centre Hospitalier Universitaire
Saint-Etienne, 42055
David HUPIN, MD-PhD, (0)4 77 82 83 00 ext. +33, david.hupin@chu-st-etienne.fr
KASRA AZARNOUSH, PHD
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation (AF), Cerebral Vascular Accident (CVA), Heart Failure, Myocardial Infarction (MI)
- Being tested
- tVNS session on the left earlobe, tVNS "SHAM" session the conchae aurea of the left ear
- Keywords
- cardiology, fibrillation, aortic valve
- Medical subject headings
- Atrial Fibrillation, Stroke, Heart Failure, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVNS session on the left earlobeOther
- 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
tVNS "SHAM" session the conchae aurea of the left earOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with active tVNS | Active comparator | Not described Receives: Other: tVNS "SHAM" session the conchae aurea of the left ear |
| patients with sham tVNS | Sham comparator | Not described Receives: Other: tVNS session on the left earlobe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (6)
Cardiac autonomic activity
Cardiac autonomic activity, as measured by HRV, will be assessed postoperatively using the RMSSD parameter (ms).
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start31 Jan 2027 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891390
- Sponsor's protocol ID
- 26CH162
- Other IDs
- ANSM
- Acronym
- VAGASTIMA-PILT
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No