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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Arrhythmias
• Intervention / Treatment: Device: HD ECG; Device: Conventional 12-lead ECG

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michel HAÏSSAGUERRE, MD-PhD; Phone Number: +33 (0)5 57 65 64 71; Email: michel.haissaguerre@chu-bordeaux.fr
• Study Contact Backup: Name: Aude CATHALA; Email: aude.cathala@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33604
    • Recruiting
    • Bordeaux university hospital
    • Sub-Investigator: Josselin DUCHATEAU, MD
    • Sub-Investigator: Romain TIXIER, MD
    • Contact: Michel HAÏSSAGUERRE, MD-PhD; Phone Number: +33 (0)5 57 65 64 71; Email: michel.haissaguerre@chu-bordeaux.fr
    • Contact: Aude CATHALA; Email: aude.cathala@chu-bordeaux.fr
    • Sub-Investigator: Frédéric SACHER, MD-PhD
    • Principal Investigator: Michel HAÏSSAGUERRE, MD-PhD
    • Sub-Investigator: Hugo MARCHAND, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Proven or suspected arrhythmias group

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Michel HAÏSSAGUERRE, MD-PhD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Anticipated): April 1, 2026
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Signal Averaging ECG; Cardiac electrophysiology
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CHUBX 2020/59

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No