NCT04921501

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Apr 2021Apr 2027

Study Start

First participant enrolled

April 6, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

6 years

First QC Date

June 4, 2021

Last Update Submit

December 19, 2024

Conditions

Ventricular Arrhythmias

Keywords

Signal Averaging ECGCardiac electrophysiology

Outcome Measures

Primary Outcomes (4)

  • Identification of the "amplitude" electrical criteria by HD ECG

    These electrical criteria are measured in millivolt (mV)

    Day 0

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

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

    Day 0

  • Identification of the "duration" electrical criteria by HD ECG

    These criteria are measured in milliseconds (ms)

    Day 0

  • Identification of "anatomical locations" electrical criteria by HD ECG

    Defined by the position of the electrodes

    Day 0

Study Arms (1)

Proven or suspected arrhythmias group

EXPERIMENTAL
Device: HD ECGDevice: Conventional 12-lead ECG

Interventions

HD ECGDEVICE

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.

Proven or suspected arrhythmias group
Conventional 12-lead ECGDEVICE

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.

Proven or suspected arrhythmias group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients under 14 years old,
  • pregnant or nursing woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Hôpital Privé Jacques Cartier

Massy, 91300, France

NOT YET RECRUITING

Hôpital Pitié-Salpêtrière

Paris, 75013, France

NOT YET RECRUITING

Hôpital Bichat

Paris, 75018, France

NOT YET RECRUITING

Hôpital européen Georges Pompidou

Paris, 75908, France

NOT YET RECRUITING

Bordeaux University Hospital

Pessac, 33604, France

RECRUITING

CHR Pontchaillou

Rennes, 35033, France

NOT YET RECRUITING

CHU de Saint-Etienne

Saint-Etienne, 42055, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, 35033, France

NOT YET RECRUITING

CHU de Nancy

Vandœuvre-lès-Nancy, 54511, France

NOT YET RECRUITING

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

NOT YET RECRUITING

Study Officials

  • Michel HAÏSSAGUERRE, MD-PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel HAÏSSAGUERRE, MD-PhD

CONTACT

(0)5 57 65 64 71michel.haissaguerre@chu-bordeaux.fr

Aude CATHALA

CONTACT

aude.cathala@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective single arm monocentric descriptive and evaluation study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 10, 2021

Study Start

April 6, 2021

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

December 24, 2024

Record last verified: 2024-12

Locations

FR(10)MO(1)