Ventricular ArrhythmiasECG-HDNCT04921501
Evaluation of Electrocardiographic Measurements by High Density Electrode ECG
A study testing HD ECG and Conventional 12-lead ECG in people with Ventricular Arrhythmias, run by University Hospital, Bordeaux at 11 sites in 2 countries.
Trial summary
Cardiac electrical activity is detected on the body surface with conventional electrocardiography involving 12 leads (ECG 12). A limitation of the current ECG technique is that recordings are obtained from only 6 independent precordial leads pairs ; which may miss cardiac potentials from spatially limited regions. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Ventricular Arrhythmias
- What is being tested?
- HD ECG and Conventional 12-lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 6 Apr 2021to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient managed at the Bordeaux University Hospital for assessment of documented severe ventricular arrhythmia (VF, sudden resuscitated death) or suspected (syncope, family history of sudden death, ECG or Holter abnormality) or impaired ventricular conduction, OR
- Patients managed for prophylactic ventricular defibrillator implantation, according to international recommendations: Heart disease with ejection fraction < 35%, heart disease with sustained ventricular tachycardia, cardiomyopathies with high rhythmic risk,
- Women of childbearing age with effective contraception.
Who cannot join
- patients under 14 years old,
- pregnant or nursing woman.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Aude CATHALA contact
11 sites in 2 countries
France10 sites, 10 recruiting
- Not yet recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Romain ESCHALIER, reschalier@chu-clermontferrand.fr
- Not yet recruiting
Hôpital Privé Jacques Cartier
Massy, 91300
Laurent FIORINA, contact@rythmo.fr
- Not yet recruiting
Hôpital Pitié-Salpêtrière
Paris, 75013
Estelle GANDJBAKHCH, estelle.gandjbakhch@aphp.fr
- Not yet recruiting
Hôpital Bichat
Paris, 75018
Fabrice EXTRAMANIA, fabrice.extramania@aphp.fr
- Not yet recruiting
Hôpital européen Georges Pompidou
Paris, 75908
Eloi MARIJON, eloi.marijon@aphp.fr
- Recruiting
Bordeaux University Hospital
Pessac, 33604
Michel HAÏSSAGUERRE, MD-PhD, (0)5 57 65 64 71 ext. +33, michel.haissaguerre@chu-bordeaux.fr
Aude CATHALA, aude.cathala@chu-bordeaux.fr
- Not yet recruiting
CHR Pontchaillou
Rennes, 35033
Raphaël MARTINS, raphael.martins@chu-rennes.fr
- Not yet recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Karim BENALI, karim.benali@univ-st-st-etienne.fr
- Not yet recruiting
CHU de Toulouse
Toulouse, 35033
Philippe MAURY, maury.p@chu-toulouse.fr
- Not yet recruiting
CHU de Nancy
Vandœuvre-lès-Nancy, 54511
Christian DE CHILLOU, c.dechillou@chru-nancy.fr
Monaco1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Princesse Grace
Monaco, 98000
Gabriel LATCU, gabriel.latcu@chpg.mc
About this study
Cardiac electrical activity is detected on the body surface with conventional electrocardiography involving 12 leads (ECG 12). A limitation of the current ECG technique is that recordings are obtained from only 6 independent precordial leads pairs ; which may miss cardiac potentials from spatially limited regions. More extensive sampling of the body surface may contribute to additional clinical information. The present study investigates the additional sensitivity of ECG using 128 body surface leads (High Density (HD) ECG) in measuring global or regional cardiac activity.
- Conditions
- Ventricular Arrhythmias
- Being tested
- HD ECG, Conventional 12-lead ECG
- Keywords
- Signal Averaging ECG, Cardiac electrophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD ECGDevice
This experimental procedure is a passive, non-invasive, high-density surface ECG recording using 128 skin electrodes.The electrodes are positioned on strips of 10 electrodes to be prepared with adhesive tape and coated with conductive gel before installation on the patient. The total duration of the acquisition is 10 to 30 minutes.
Conventional 12-lead ECGDevice
This standard 12-lead ECG is defined on the HD ECG, from electrodes F13, G3, G14, H5, H15, H25 corresponding to the precordial electrodes. 4 limb electrodes will be added for the frontal leads. Thus, the HD and 12-lead ECGs will be obtained simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Proven or suspected arrhythmias group | Experimental | Not described Receives: Device: HD ECG; Device: Conventional 12-lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the "amplitude" electrical criteria by HD ECG
These electrical criteria are measured in millivolt (mV)
Measured: Day 0
Identification of the "cardiac time" electrical criteria by HD ECG
Defined by the auricular cardiac time, ventricular depolarization and repolarization time
Measured: Day 0
Identification of the "duration" electrical criteria by HD ECG
These criteria are measured in milliseconds (ms)
Measured: Day 0
Identification of "anatomical locations" electrical criteria by HD ECG
Defined by the position of the electrodes
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start6 Apr 2021
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiasStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single arm monocentric descriptive and evaluation study.
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel HAÏSSAGUERRE, MD-PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921501
- Sponsor's protocol ID
- CHUBX 2020/59
- Acronym
- ECG-HD
- Status last verified
- Dec 2024
- First submitted
- 4 Jun 2021
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Electrocardiographic Measurements by High Density Electrode ECG
- ClinicalTrials.gov ID
- NCT04921501
- Acronym / sponsor ID
- ECG-HD / CHUBX 2020/59
- Conditions
- Ventricular Arrhythmias
- Keywords
- Signal Averaging ECG, Cardiac electrophysiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 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.
Cardiac electrical activity is detected on the body surface with conventional electrocardiography involving 12 leads (ECG 12). A limitation of the current ECG technique is that recordings are obtained from only 6 independent precordial leads pairs ; which may miss cardiac potentials from spatially limited regions. More extensive sampling of the body surface may contribute to additional clinical information. The present study investigates the additional sensitivity of ECG using 128 body surface leads (High Density (HD) ECG) in measuring global or regional cardiac activity.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single arm monocentric descriptive and evaluation study.
| Arm | Type | Receives |
|---|---|---|
| Proven or suspected arrhythmias group | Experimental | Device: HD ECG, Device: Conventional 12-lead ECG |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient managed at the Bordeaux University Hospital for assessment of documented severe ventricular arrhythmia (VF, sudden resuscitated death) or suspected (syncope, family history of sudden death, ECG or Holter abnormality) or impaired ventricular conduction, OR
- Patients managed for prophylactic ventricular defibrillator implantation, according to international recommendations: Heart disease with ejection fraction < 35%, heart disease with sustained ventricular tachycardia, cardiomyopathies with high rhythmic risk,
- Women of childbearing age with effective contraception.
Key exclusion criteria (2 listed)
- patients under 14 years old,
- pregnant or nursing woman.
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 |
|---|---|---|
| HD ECGThis experimental procedure is a passive, non-invasive, high-density surface ECG recording using 128 skin electrodes.The electrodes are positioned on strips of 10 electrodes to be prepared with adhesive tape and coated with conductive gel before installation on the patient. The total duration of the acquisition is 10 to 30 minutes. | Device | Proven or suspected arrhythmias group |
| Conventional 12-lead ECGThis standard 12-lead ECG is defined on the HD ECG, from electrodes F13, G3, G14, H5, H15, H25 corresponding to the precordial electrodes. 4 limb electrodes will be added for the frontal leads. Thus, the HD and 12-lead ECGs will be obtained simultaneously. | Device | Proven or suspected arrhythmias group |
Primary outcome
Identification of the "amplitude" electrical criteria by HD ECG
Time frame: Day 0
These electrical criteria are measured in millivolt (mV)
Identification of the "cardiac time" electrical criteria by HD ECG
Time frame: Day 0
Defined by the auricular cardiac time, ventricular depolarization and repolarization time
Identification of the "duration" electrical criteria by HD ECG
Time frame: Day 0
These criteria are measured in milliseconds (ms)
Identification of "anatomical locations" electrical criteria by HD ECG
Time frame: Day 0
Defined by the position of the electrodes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
Related trials for Ventricular Arrhythmias
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
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.
Aude CATHALA contact
Michel HAÏSSAGUERRE, MD-PhD principal investigator
University Hospital, Bordeaux
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD ECG and Conventional 12-lead ECG in people with Ventricular Arrhythmias, run by University Hospital, Bordeaux at 11 sites in 2 countries.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Monaco. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel HAÏSSAGUERRE, MD-PhD ((0)5 57 65 64 71 ext. +33, michel.haissaguerre@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the "amplitude" electrical criteria by HD ECG (time frame: Day 0). The study lists 4 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 24 Dec 2024.