Sudden DeathSKNANCT04918303
Skin Sympathetic Nerve Activity and Cardiac Arrhythmia
A study testing SKNA recording in people with Sudden Death and Ventricular Tachycardia, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Death, Ventricular Tachycardia, Persistent Atrial Fibrillation
- What is being tested?
- SKNA recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2021to 12 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy,
- patient under 18 year old,
- patient with a cardiac stimulation device
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- SKNA recording
- Keywords
- Skin sympathetic nerve activity (SKNA), Electrocardiogram (ECG), Cardiac arrythmia
- Medical subject headings
- Death, Sudden, Tachycardia, Ventricular, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKNA recordingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| SKNA group | Experimental | Not described Receives: Device: SKNA recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start3 May 2021
- Primary completion12 Oct 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden DeathStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mélèze Hocini, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918303
- Sponsor's protocol ID
- CHUBX 2020/55
- Acronym
- SKNA
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2021
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Sympathetic Nerve Activity and Cardiac Arrhythmia
- ClinicalTrials.gov ID
- NCT04918303
- Acronym / sponsor ID
- SKNA / CHUBX 2020/55
- Keywords
- Skin sympathetic nerve activity (SKNA), Electrocardiogram (ECG), Cardiac arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKNA group | Experimental | Device: SKNA recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy,
- patient under 18 year old,
- patient with a cardiac stimulation device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKNA recordingThe 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 | Device | SKNA group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélèze Hocini, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKNA recording in people with Sudden Death and Ventricular Tachycardia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay between the discharge of the sympathetic system and the rhythmic event. (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.