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

Ventricular Arrhythmias Clinical Trial

— ECG-HD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921501
• Other study ID #: CHUBX 2020/59
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: April 2026

Study information

• Verified date: April 2021
• Source: University Hospital, Bordeaux
• Contact: Michel HAÏSSAGUERRE, MD-PhD
• Phone: (0)5 57 65 64 71
• Email: michel.haissaguerre[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ventricular Arrhythmias

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the "amplitude" electrical criteria by HD ECG	These electrical criteria are measured in millivolt (mV)	Day 0
Primary	Identification of the "cardiac time" electrical criteria by HD ECG	Defined by the auricular cardiac time, ventricular depolarization and repolarization time	Day 0
Primary	Identification of the "duration" electrical criteria by HD ECG	These criteria are measured in milliseconds (ms)	Day 0
Primary	Identification of "anatomical locations" electrical criteria by HD ECG	Defined by the position of the electrodes	Day 0