Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

Not Applicable

Recruiting

• Conditions: Ventricular Arrhythmias
• Interventions: Device: HD ECG; Device: Conventional 12-lead ECG

• Registration Number: NCT04921501
• Lead Sponsor: University Hospital, Bordeaux

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-06
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proven or suspected arrhythmias group	HD ECG	-
Proven or suspected arrhythmias group	Conventional 12-lead ECG	-

Primary Outcome Measures

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

Trial Locations

Locations (11)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

Hôpital Bichat; 🇫🇷 Paris, France

Hôpital européen Georges Pompidou; 🇫🇷 Paris, France

Bordeaux University Hospital; 🇫🇷 Pessac, France

CHR Pontchaillou; 🇫🇷 Rennes, France

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Nancy; 🇫🇷 Vandoeuvre les Nancy, France

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco