Skin Sympathetic Nerve Activity and Cardiac Arrhythmia

NCT04918303 | Completed

• 1 other identifier: CHUBX 2020/55
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Sudden Death; Ventricular Tachycardia; Persistent Atrial Fibrillation

Keywords

Skin sympathetic nerve activity (SKNA); Electrocardiogram (ECG); Cardiac arrythmia

Outcome Measures

Primary Outcomes (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.

  Day 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.

  Day 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.

  Month 6

Study Arms (1)

SKNA group

EXPERIMENTAL

Device: SKNA recording

Interventions

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

SKNA group

Eligibility Criteria

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

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, 33600, France

Location

MeSH Terms

Conditions

Death, Sudden; Tachycardia, Ventricular; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease

Study Officials

• Mélèze Hocini, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: May 3, 2021
• Primary Completion: October 12, 2023
• Study Completion: October 12, 2023
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

FR (1)