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Skin Sympathetic Nerve Activity and Cardiac Arrhythmia (SKNA)

Primary Purpose

Sudden Death, Ventricular Tachycardia, Persistent Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SKNA recording
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sudden Death focused on measuring Skin sympathetic nerve activity (SKNA), Electrocardiogram (ECG), Cardiac arrythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bordeaux University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SKNA group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2021
Last Updated
June 2, 2021
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04918303
Brief Title
Skin Sympathetic Nerve Activity and Cardiac Arrhythmia
Acronym
SKNA
Official Title
Skin Sympathetic Nerve Activity and Cardiac Arrhythmia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
November 3, 2023 (Anticipated)
Study Completion Date
November 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Death, Ventricular Tachycardia, Persistent Atrial Fibrillation
Keywords
Skin sympathetic nerve activity (SKNA), Electrocardiogram (ECG), Cardiac arrythmia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SKNA group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SKNA recording
Intervention Description
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 Outcome Measure Information:
Title
Delay between the discharge of the sympathetic system and the rhythmic event.
Description
Temporal correlation of occurrence of sympathetic electrical event and cardiac arrhythmia by the MacNemar test will be performed.
Time Frame
Day 1
Title
Delay between the discharge of the sympathetic system and the rhythmic event.
Description
Temporal correlation of occurrence of sympathetic electrical event and cardiac arrhythmia by the MacNemar test will be performed.
Time Frame
Day 2
Title
Delay between the discharge of the sympathetic system and the rhythmic event.
Description
Temporal correlation of occurrence of sympathetic electrical event and cardiac arrhythmia by the MacNemar test will be performed.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mélèze Hocini, MD
Phone
(0)5 57 63 34 06
Ext
+33
Email
meleze.hocini@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maëlle Vallade
Phone
(0)5 24 54 92 58
Ext
+33
Email
maelle.vallade@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mélèze Hocini, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélèze Hocini, MD
Phone
(0)5 57 63 34 06
Ext
+33
Email
meleze.hocini@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Maëlle Vallade
Phone
(0)5 24 54 92 58
Ext
+33
Email
maelle.vallade@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Mélèze Hocini, MD

12. IPD Sharing Statement

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