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

Primary Purpose

Ventricular Arrhythmias

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

HD ECG

Conventional 12-lead ECG

About this trial

This is an interventional other trial for Ventricular Arrhythmias focused on measuring Signal Averaging ECG, Cardiac electrophysiology

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Bordeaux University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proven or suspected arrhythmias group

Arm Description

Outcomes

Primary Outcome Measures

Identification of the "amplitude" electrical criteria by HD ECG

These electrical criteria are measured in millivolt (mV)

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

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

Identification of the "duration" electrical criteria by HD ECG

These criteria are measured in milliseconds (ms)

Identification of "anatomical locations" electrical criteria by HD ECG

Defined by the position of the electrodes

Secondary Outcome Measures

Full Information

NCT ID

NCT04921501

First Posted

June 4, 2021

Last Updated

June 4, 2021

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT04921501

Brief Title

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

Acronym

ECG-HD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

April 6, 2021 (Actual)

Primary Completion Date

April 2026 (Anticipated)

Study Completion Date

April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Arrhythmias

Keywords

Signal Averaging ECG, Cardiac electrophysiology

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective single arm monocentric descriptive and evaluation study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proven or suspected arrhythmias group

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

HD ECG

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Conventional 12-lead ECG

Intervention Description

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 Measure Information:

Title

Identification of the "amplitude" electrical criteria by HD ECG

Description

These electrical criteria are measured in millivolt (mV)

Time Frame

Day 0

Title

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

Description

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

Time Frame

Day 0

Title

Identification of the "duration" electrical criteria by HD ECG

Description

These criteria are measured in milliseconds (ms)

Time Frame

Day 0

Title

Identification of "anatomical locations" electrical criteria by HD ECG

Description

Defined by the position of the electrodes

Time Frame

Day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michel HAÏSSAGUERRE, MD-PhD

Phone

(0)5 57 65 64 71

Ext

+33

michel.haissaguerre@chu-bordeaux.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Aude CATHALA

aude.cathala@chu-bordeaux.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel HAÏSSAGUERRE, MD-PhD

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bordeaux University Hospital

City

Pessac

ZIP/Postal Code

33604

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michel HAÏSSAGUERRE, MD-PhD

Phone

(0)5 57 65 64 71

Ext

+33

michel.haissaguerre@chu-bordeaux.fr

First Name & Middle Initial & Last Name & Degree

Aude CATHALA

aude.cathala@chu-bordeaux.fr

First Name & Middle Initial & Last Name & Degree

Frédéric SACHER, MD-PhD

First Name & Middle Initial & Last Name & Degree

Michel HAÏSSAGUERRE, MD-PhD

First Name & Middle Initial & Last Name & Degree

Josselin DUCHATEAU, MD

First Name & Middle Initial & Last Name & Degree

Romain TIXIER, MD

First Name & Middle Initial & Last Name & Degree

Hugo MARCHAND, MD

12. IPD Sharing Statement

Learn more about this trial

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

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