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Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

NCT04921501 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2024-12-24

No results posted yet for this 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.

Conditions

  • Ventricular Arrhythmias

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Michel HAÏSSAGUERRE, MD-PhD · University Hospital, Bordeaux

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • France
  • Monaco

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921501 on ClinicalTrials.gov