Skin Sympathetic Nerve Activity and Cardiac Arrhythmia

Ventricular Tachycardia Clinical Trial

— SKNA  

Official title:

Skin Sympathetic Nerve Activity and Cardiac Arrhythmia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918303
• Other study ID #: CHUBX 2020/55
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: October 12, 2023

Study information

• Verified date: May 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 12, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Death, Sudden
• Persistent Atrial Fibrillation
• Sudden Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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