Evaluation of Electrocardiographic Measurements by High Density Electrode ECG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HD ECG, Conventional 12-lead ECG.
- Who it may be relevant to
- Registry conditions: Ventricular Arrhythmias. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Monaco
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device HD ECG
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. - Device Conventional 12-lead ECG
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.
Primary outcome measures
- Identification of the "amplitude" electrical criteria by HD ECG [Time frame: Day 0]
- Identification of the "cardiac time" electrical criteria by HD ECG [Time frame: Day 0]
- Identification of the "duration" electrical criteria by HD ECG [Time frame: Day 0]
- Identification of "anatomical locations" electrical criteria by HD ECG [Time frame: Day 0]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 10 centers
- CHU Clermont-Ferrand — Clermont-Ferrand
- Hôpital Privé Jacques Cartier — Massy
- Hôpital Pitié-Salpêtrière — Paris
- Hôpital Bichat — Paris
- Hôpital européen Georges Pompidou — Paris
- Bordeaux University Hospital — Pessac
- CHR Pontchaillou — Rennes
- CHU de Saint-Etienne — Saint-Etienne
- … and 2 more centers
Monaco · 1 center
- Centre Hospitalier Princesse Grace — Monaco
Identifiers
NCT: NCT04921501 · CHUBX 2020/59