Skin Sympathetic Nerve Activity and Cardiac Arrhythmia (SKNA)

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

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia; Persistent Atrial Fibrillation; Sudden Death
• Intervention / Treatment: Device: SKNA recording

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mélèze Hocini, MD; Phone Number: +33 (0)5 57 63 34 06; Email: meleze.hocini@chu-bordeaux.fr
• Study Contact Backup: Name: Maëlle Vallade; Phone Number: +33 (0)5 24 54 92 58; Email: maelle.vallade@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33600
    • Recruiting
    • Bordeaux University Hospital
    • Contact: Mélèze Hocini, MD; Phone Number: +33 (0)5 57 63 34 06; Email: meleze.hocini@chu-bordeaux.fr
    • Contact: Maëlle Vallade; Phone Number: +33 (0)5 24 54 92 58; Email: maelle.vallade@chu-bordeaux.fr
    • Principal Investigator: Mélèze Hocini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SKNA group	Device: SKNA 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Mélèze Hocini, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Anticipated): November 3, 2023
• Study Completion (Anticipated): November 3, 2023

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Electrocardiogram (ECG); Skin sympathetic nerve activity (SKNA); Cardiac arrythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Death; Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Death, Sudden
• Other Study ID Numbers: CHUBX 2020/55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No