NCT07891390Not yet recruiting
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation
Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation Prior to Aortic Valve Surgery VAGASTIMA - PILOT: a Multicenter, Randomized Study
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- 31 Jan 2027
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- NCT number
- NCT07891390
What you commit to
- Study type: Interventional
- Planned participants: 64
- From 31 Jan 2027 to the primary completion date, 31 Mar 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-existing FA prior to surgery,
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| MAUREIRA Juan-Pablo Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Centre Hospitalier Universitaire Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.