Health Trials

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

ConditionVentricular Arrhythmias
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorUniversity Hospital, Bordeaux

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

patients under 14 years old,

pregnant or nursing woman.

Trial design

Design model

Single group

Treatments tested in this trial

  • HD ECG

    Device

    This experimental procedure is a passive, non-invasive, high-density surface ECG recording using 128 skin electrodes.The electrodes are positioned on strips of 10 electrodes to be prepared with adhesive tape and coated with conductive gel before installation on the patient. The total duration of the acquisition is 10 to 30 minutes.

  • Conventional 12-lead ECG

    Device

    This standard 12-lead ECG is defined on the HD ECG, from electrodes F13, G3, G14, H5, H15, H25 corresponding to the precordial electrodes. 4 limb electrodes will be added for the frontal leads. Thus, the HD and 12-lead ECGs will be obtained simultaneously.

Treatment groups

1,800 Participants
are divided into 1 treatment group
Group A: Proven or suspected arrhythmias groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Identification of the "amplitude" electrical criteria by HD ECG

These electrical criteria are measured in millivolt (mV)

Time frame
Day 0
2

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

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

Time frame
Day 0
3

Identification of the "duration" electrical criteria by HD ECG

These criteria are measured in milliseconds (ms)

Time frame
Day 0
4

Identification of "anatomical locations" electrical criteria by HD ECG

Defined by the position of the electrodes

Time frame
Day 0

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov
Apply now