ClinicalTrials.gg
Sign In
CompletedNCT04918303SKNAUpdated Jun 17, 2025

Skin Sympathetic Nerve Activity and Cardiac Arrhythmia

An interventional study of SKNA recording in Sudden Death, Ventricular Tachycardia and Persistent Atrial Fibrillation, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Sympathetic tone is important in cardiac arrhythmogenesis. The simultaneous recording of sympathetic nerve activity (SNA) and electrocardiogram (ECG) was obtained by invasive method. The purpose of this protocol is to further develop this recording method to turn it into a new non-invasive tool for arrhythmia prediction and detection. This method may also be useful in validating the results of surgical procedures aimed at sympathetic denervation

02

Conditions studied

  • Sudden Death
  • Ventricular Tachycardia
  • Persistent Atrial Fibrillation

Keywords

  • Skin sympathetic nerve activity (SKNA)
  • Electrocardiogram (ECG)
  • Cardiac arrythmia
03

In context

Death, Sudden

66 studies on the registry are indexed under Death, Sudden; 5 are open to participants now.

This study's enrollment of 100 is below the median of 168 across 28 interventional studies indexed under Death, Sudden.

Browse Death, Sudden studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.

Browse University Hospital, Bordeaux studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patient hospitalized at Bordeaux University Hospital for sudden death, ventricular tachycardia, persistent or paroxysmal atrial fibrillation treated by ablation and/or vein of Marshall ethanol infusion

Exclusion criteria

Exclusion Criteria:

  • pregnancy,
  • patient under 18 year old,
  • patient with a cardiac stimulation device
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    SKNA group

    Device: SKNA recording

Interventions

  • DeviceSKNA recording

    The coupled recording of the sympathetic nervous activity of the skin and of an ECG will be carried out using the ME6000 device, CE marked, from the Bittium company. It will be performed for a maximum period of one hour at Day 1, Post-procedure between Day 1 and discharge from hospital, and month 6

06

What researchers measure

Primary outcomes

  1. Delay between the discharge of the sympathetic system and the rhythmic event.

    Temporal correlation of occurrence of sympathetic electrical event and cardiac arrhythmia by the MacNemar test will be performed.

    Time frame: Day 1

  2. Delay between the discharge of the sympathetic system and the rhythmic event.

    Temporal correlation of occurrence of sympathetic electrical event and cardiac arrhythmia by the MacNemar test will be performed.

    Time frame: Day 2

  3. Delay between the discharge of the sympathetic system and the rhythmic event.

    Temporal correlation of occurrence of sympathetic electrical event and cardiac arrhythmia by the MacNemar test will be performed.

    Time frame: Month 6

07

Study locations

1 site
  • Bordeaux University Hospital
    Pessac, 33600, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2021 to primary completion in Oct 2023, 29 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2021
First posted
Jun 8, 2021
StartActual
May 3, 2021
Primary completionActual
Oct 12, 2023
CompletionActual
Oct 12, 2023
Last update
Jun 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04918303
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Jun 8, 2021
Start date
May 3, 2021
Primary completion
Oct 12, 2023
Completion
Oct 12, 2023
Last update
Jun 17, 2025

Study contacts

Mélèze Hocini, MD
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Death, Sudden →

Other studies from this sponsor

University Hospital, Bordeaux →

Start the discussion