Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventricular Arrhythmias

Keywords

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Signal Averaging ECG Cardiac electrophysiology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective single arm monocentric descriptive and evaluation study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Proven or suspected arrhythmias group

Group Type EXPERIMENTAL

HD ECG

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel HAÏSSAGUERRE, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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