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Completed

NCT Number: NCT04918303

Skin Sympathetic Nerve Activity and Cardiac Arrhythmia

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

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Key information

Conditions

Sudden Death Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Atrial Fibrillation Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital

Pessac, 33600, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

SKNA recording

Device

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

Primary outcomes

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

    Time frame: Day 1

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

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

    Time frame: Day 2

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

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

    Time frame: Month 6

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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: SKNA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2021
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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