ClinicalTrials.gg
RecruitingNCT04921501ECG-HDUpdated Dec 24, 2024

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

An interventional study of HD ECG and Conventional 12-lead ECG in Ventricular Arrhythmias, sponsored by University Hospital, Bordeaux. Recruiting at 11 sites in 2 countries. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,800
Allocation
Not applicable
Ages
14 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Ventricular Arrhythmias

Keywords

  • Signal Averaging ECG
  • Cardiac electrophysiology
03

In context

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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, or Holter abnormality) or impaired ventricular conduction, OR
  • Patients managed for prophylactic ventricular defibrillator implantation, according to international recommendations: Heart disease with \< 35%, heart disease with sustained ventricular tachycardia, cardiomyopathies with high rhythmic risk,
  • Women of childbearing age with effective .

Exclusion criteria

Exclusion Criteria:

  • patients under 14 years old,
  • pregnant or nursing woman.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,800 participants (estimated)

Study arms

  • Experimental
    Proven or suspected arrhythmias group

    Device: HD ECG · Device: Conventional 12-lead ECG

Interventions

  • DeviceHD ECG

    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.

  • DeviceConventional 12-lead ECG

    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.

06

What researchers measure

Primary outcomes

  1. Identification of the "amplitude" electrical criteria by HD ECG

    These electrical criteria are measured in millivolt (mV)

    Time frame: Day 0

  2. Identification of the "cardiac time" electrical criteria by HD ECG

    Defined by the auricular cardiac time, ventricular depolarization and repolarization time

    Time frame: Day 0

  3. Identification of the "duration" electrical criteria by HD ECG

    These criteria are measured in milliseconds (ms)

    Time frame: Day 0

  4. Identification of "anatomical locations" electrical criteria by HD ECG

    Defined by the position of the electrodes

    Time frame: Day 0

07

Study locations

1 of 11 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2021 (actual). Primary completion is estimated for Apr 2027, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2021
First posted
Jun 10, 2021
StartActual
Apr 6, 2021
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Dec 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04921501
Responsible party
Sponsor
First posted
Jun 10, 2021
Start date
Apr 6, 2021
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Dec 24, 2024

Study contacts

Michel HAÏSSAGUERRE, MD-PhD
Contact
michel.haissaguerre@chu-bordeaux.fr
(0)5 57 65 64 71 ext. +33
Aude CATHALA
Contact
aude.cathala@chu-bordeaux.fr
Michel HAÏSSAGUERRE, MD-PhD
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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