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Recruiting Not applicable

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

NCT04921501 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-04-06
Last updated
2024-12-24

Condition(s) studied

Ventricular Arrhythmias

Investigational drug(s) / intervention(s)

HD ECGConventional 12-lead ECG

HD 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.

Conventional 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.

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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
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, 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. Exclusion Criteria: * patients under 14 years old, * pregnant or nursing woman.

Primary outcome measure(s)

  • Identification of the "amplitude" electrical criteria by HD ECG — Day 0
    These electrical criteria are measured in millivolt (mV)
  • Identification of the "cardiac time" electrical criteria by HD ECG — Day 0
    Defined by the auricular cardiac time, ventricular depolarization and repolarization time
  • Identification of the "duration" electrical criteria by HD ECG — Day 0
    These criteria are measured in milliseconds (ms)
  • Identification of "anatomical locations" electrical criteria by HD ECG — Day 0
    Defined by the position of the electrodes

Trial sites (11)

FacilityCityRegionStatus
CHU Clermont-Ferrand Clermont-Ferrand France Not Yet Recruiting
Hôpital Privé Jacques Cartier Massy France Not Yet Recruiting
Hôpital Pitié-Salpêtrière Paris France Not Yet Recruiting
Hôpital Bichat Paris France Not Yet Recruiting
Hôpital européen Georges Pompidou Paris France Not Yet Recruiting
Bordeaux University Hospital Pessac France Recruiting
CHR Pontchaillou Rennes France Not Yet Recruiting
CHU de Saint-Etienne Saint-Etienne France Not Yet Recruiting
CHU de Toulouse Toulouse France Not Yet Recruiting
CHU de Nancy Vandœuvre-lès-Nancy France Not Yet Recruiting
Centre Hospitalier Princesse Grace Monaco Monaco Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04921501 on ClinicalTrials.gov ↗ ← All trials in France