RecruitingNot ApplicableNCT04921501

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG


Sponsor

University Hospital, Bordeaux

Enrollment

1,800 participants

Start Date

Apr 6, 2021

Study Type

INTERVENTIONAL

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

Min Age: 14 Years

Inclusion Criteria3

  • 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 Criteria2

  • patients under 14 years old,
  • pregnant or nursing woman.

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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.


Locations(11)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Hôpital Privé Jacques Cartier

Massy, France

Hôpital Pitié-Salpêtrière

Paris, France

Hôpital Bichat

Paris, France

Hôpital européen Georges Pompidou

Paris, France

Bordeaux University Hospital

Pessac, France

CHR Pontchaillou

Rennes, France

CHU de Saint-Etienne

Saint-Etienne, France

CHU de Toulouse

Toulouse, France

CHU de Nancy

Vandœuvre-lès-Nancy, France

Centre Hospitalier Princesse Grace

Monaco, Monaco

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NCT04921501