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

U

University Hospital of Bordeaux

Status

Enrolling

Conditions

Ventricular Arrhythmias

Treatments

Device: Conventional 12-lead ECG
Device: HD ECG

Study type

Interventional

Funder types

Other

Identifiers

NCT04921501
CHUBX 2020/59

Details and patient eligibility

About

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.

Enrollment

1,800 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,800 participants in 1 patient group

Proven or suspected arrhythmias group
Experimental group
Treatment:
Device: HD ECG
Device: Conventional 12-lead ECG

Trial contacts and locations

11

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Central trial contact

Michel HAÏSSAGUERRE, MD-PhD; Aude CATHALA

Data sourced from clinicaltrials.gov

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