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Clinical Trials/NCT04921501
NCT04921501
Recruiting
Not Applicable

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

University Hospital, Bordeaux11 sites in 2 countries1,800 target enrollmentApril 6, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Arrhythmias
Sponsor
University Hospital, Bordeaux
Enrollment
1800
Locations
11
Primary Endpoint
Identification of the "amplitude" electrical criteria by HD ECG
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 6, 2021
End Date
April 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Identification of the "amplitude" electrical criteria by HD ECG

Time Frame: Day 0

These electrical criteria are measured in millivolt (mV)

Identification of the "cardiac time" electrical criteria by HD ECG

Time Frame: Day 0

Defined by the auricular cardiac time, ventricular depolarization and repolarization time

Identification of the "duration" electrical criteria by HD ECG

Time Frame: Day 0

These criteria are measured in milliseconds (ms)

Identification of "anatomical locations" electrical criteria by HD ECG

Time Frame: Day 0

Defined by the position of the electrodes

Study Sites (11)

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