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

December 19, 2024 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
      • Massy, France, 91300
        • Not yet recruiting
        • Hopital Prive Jacques Cartier
        • Contact:
      • Paris, France, 75013
      • Paris, France, 75018
      • Paris, France, 75908
        • Not yet recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
      • Pessac, France, 33604
        • Recruiting
        • Bordeaux University Hospital
        • Contact:
        • Contact:
        • Contact:
          • Frédéric SACHER, MD-PhD
        • Contact:
          • Michel HAÏSSAGUERRE, MD-PhD
        • Contact:
          • Josselin DUCHATEAU, MD
        • Contact:
          • Romain TIXIER, MD
        • Contact:
          • Hugo MARCHAND, MD
      • Rennes, France, 35033
      • Saint-Etienne, France, 42055
      • Toulouse, France, 35033
      • Vandoeuvre les Nancy, France, 54511
  • Monaco
      • Monaco, Monaco, 98000
        • Not yet recruiting
        • Centre Hospitalier Princesse Grace
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proven or suspected arrhythmias group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of the "amplitude" electrical criteria by HD ECG
Time Frame: Day 0
These electrical criteria are measured in millivolt (mV)
Day 0
Identification of the "cardiac time" electrical criteria by HD ECG
Time Frame: Day 0
Defined by the auricular cardiac time, ventricular depolarization and repolarization time
Day 0
Identification of the "duration" electrical criteria by HD ECG
Time Frame: Day 0
These criteria are measured in milliseconds (ms)
Day 0
Identification of "anatomical locations" electrical criteria by HD ECG
Time Frame: Day 0
Defined by the position of the electrodes
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Michel HAÏSSAGUERRE, MD-PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2020/59

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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