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Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04921501
Acronym
ECG-HD
Enrollment
1800
Registered
2021-06-10
Start date
2021-04-06
Completion date
2027-04-30
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Arrhythmias

Keywords

Signal Averaging ECG, Cardiac electrophysiology

Brief 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.

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.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Prospective single arm monocentric descriptive and evaluation study.

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Identification of anatomical locations electrical criteria by HD ECGDay 0Defined by the position of the electrodes
Identification of the amplitude electrical criteria by HD ECGDay 0These electrical criteria are measured in millivolt (mV)
Identification of the cardiac time electrical criteria by HD ECGDay 0Defined by the auricular cardiac time, ventricular depolarization and repolarization time
Identification of the duration electrical criteria by HD ECGDay 0These criteria are measured in milliseconds (ms)

Countries

France, Monaco

Contacts

Primary ContactMichel HAÏSSAGUERRE, MD-PhD
michel.haissaguerre@chu-bordeaux.fr(0)5 57 65 64 71
Backup ContactAude CATHALA
aude.cathala@chu-bordeaux.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026