Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

Last updated: December 19, 2024
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

HD ECG

Conventional 12-lead ECG

Clinical Study ID

NCT04921501
CHUBX 2020/59
  • Ages > 14
  • All Genders

Study 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

Inclusion Criteria:

  • Patient managed at the Bordeaux University Hospital for assessment of documentedsevere ventricular arrhythmia (VF, sudden resuscitated death) or suspected (syncope,family history of sudden death, ECG or Holter abnormality) or impaired ventricularconduction, OR

  • Patients managed for prophylactic ventricular defibrillator implantation, accordingto international recommendations: Heart disease with ejection fraction < 35%, heartdisease with sustained ventricular tachycardia, cardiomyopathies with high rhythmicrisk,

  • Women of childbearing age with effective contraception.

Exclusion

Exclusion Criteria:

  • patients under 14 years old,

  • pregnant or nursing woman.

Study Design

Total Participants: 1800
Treatment Group(s): 2
Primary Treatment: HD ECG
Phase:
Study Start date:
April 06, 2021
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Hôpital Privé Jacques Cartier

    Massy, 91300
    France

    Site Not Available

  • Hôpital Bichat

    Paris, 75018
    France

    Site Not Available

  • Hôpital Pitié-Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Hôpital européen Georges Pompidou

    Paris, 75908
    France

    Site Not Available

  • Bordeaux University Hospital

    Pessac, 33604
    France

    Active - Recruiting

  • CHR Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • CHU de Saint-Etienne

    Saint-Etienne, 42055
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse, 35033
    France

    Site Not Available

  • CHU de Nancy

    Vandoeuvre les Nancy, 54511
    France

    Site Not Available

  • Centre Hospitalier Princesse Grace

    Monaco, 98000
    Monaco

    Site Not Available

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