Clinical trial NCT04921501: Evaluation of Electrocardiographic Measurements by High Density Electrode ECG
Official title: Evaluation of Electrocardiographic Measurements by High Density Electrode ECG
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Arrhythmias
Keywords: Signal Averaging ECG
Cardiac electrophysiology
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 1800
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single arm monocentric descriptive and evaluation study.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Identification of the "amplitude" electrical criteria by HD ECG
timeFrame: Day 0
measure: Identification of the "cardiac time" electrical criteria by HD ECG
timeFrame: Day 0
measure: Identification of the "duration" electrical criteria by HD ECG
timeFrame: Day 0
measure: Identification of "anatomical locations" electrical criteria by HD ECG
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
city: Pessac
country: France
facility: Bordeaux University Hospital
city: Rennes
country: France
facility: CHR Pontchaillou
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: CHU de Toulouse
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: University Hospital, Bordeaux
name: Michel HAÏSSAGUERRE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: