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NCT Number: NCT04921501

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

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.

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Key information

Conditions

Ventricular Arrhythmias

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HD ECG

Device

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

Device

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.

Primary outcomes

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

    Time frame: Day 0

    These electrical criteria are measured in millivolt (mV)

  2. 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

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

    Time frame: Day 0

    These criteria are measured in milliseconds (ms)

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

    Time frame: Day 0

    Defined by the position of the electrodes

Study contacts

Contact information is provided by the study sponsor or research team.

Aude CATHALA

CONTACT

[email protected]

Michel HAÏSSAGUERRE, MD-PhD

CONTACT

[email protected]

(0)5 57 65 64 71 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: ECG-HD

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2021
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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