Evaluation of Electrocardiographic Measurements by High Density Electrode ECG (ECG-HD)

Study Overview
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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.

Official Title
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Evaluation of Electrocardiographic Measurements by High Density Electrode ECG (ECG-HD)

Conditions
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Ventricular Arrhythmias

Intervention / Treatment
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* Device: HD ECG
* Device: Conventional 12-lead ECG


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective single arm monocentric descriptive and evaluation study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proven or suspected arrhythmias group<br> | Device: HD ECG<br>* 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.<br>Device: Conventional 12-lead ECG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the amplitude electrical criteria by HD ECG | These electrical criteria are measured in millivolt (mV) | Day 0 | 
| Identification of the cardiac time electrical criteria by HD ECG | Defined by the auricular cardiac time, ventricular depolarization and repolarization time | Day 0 | 
| Identification of the duration electrical criteria by HD ECG | These criteria are measured in milliseconds (ms) | Day 0 | 
| Identification of anatomical locations electrical criteria by HD ECG | Defined by the position of the electrodes | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Signal Averaging ECG, Cardiac electrophysiology