Actively Recruiting

Phase Not Applicable
Age: 14Years +
All Genders
ID04921501

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

Led by University Hospital, Bordeaux · Updated on 2024-12-24

1800

Participants Needed

11

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new method to record the heart's electrical activity using a high-density electrocardiogram (HD ECG) with 128 electrodes placed on the body surface. This method aims to capture more detailed cardiac signals compared to the conventional 12-lead ECG, which measures electrical activity from fewer locations and may miss signals from certain areas. The study focuses on patients with ventricular arrhythmias or related heart conditions to see if HD ECG provides additional clinical information. The study involves two types of ECG recordings done simultaneously: the standard 12-lead ECG and the experimental HD ECG device. The HD ECG uses 128 skin electrodes arranged in strips, prepared with adhesive tape and conductive gel, recording for 10 to 30 minutes. The conventional 12-lead ECG is derived from specific electrodes within the HD ECG setup, plus four limb electrodes for frontal leads. Participants include those with documented or suspected severe ventricular arrhythmias or those undergoing preventive ventricular defibrillator implantation. Participants will undergo both ECG recordings on the same day, during which researchers will identify electrical criteria such as amplitude, timing, duration, and anatomical locations of cardiac activity using the HD ECG. The study measures these outcomes to assess the sensitivity of the HD ECG method. The trial is non-blinded and conducted at Bordeaux University Hospital, with patient safety monitored throughout the recording process. The total participation involves one study visit for the ECG assessments.

CONDITIONS

Brief Title

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient managed at Bordeaux University Hospital for documented severe ventricular arrhythmia (VF, sudden resuscitated death) or suspected arrhythmia (syncope, family history of sudden death, ECG or Holter abnormality) or impaired ventricular conduction
  • Patients managed for prophylactic ventricular defibrillator implantation, based on international recommendations
  • Heart disease with ejection fraction less than 35%
  • Heart disease with sustained ventricular tachycardia
  • Cardiomyopathies with high rhythmic risk
  • Women of childbearing age using effective contraception
  • Age 14 years or older
Not Eligible

You will not qualify if you...

  • Patients under 14 years old
  • Pregnant or nursing women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 10 to 30 minutes

Participants undergo high-density surface ECG recording using 128 skin electrodes, along with simultaneous conventional 12-lead ECG measurements.

1 visit (in-person)

Trial Site Locations

Total: 11 locations

1

CHU Clermont-Ferrand

Clermont-Ferrand, France, 63000

Not Yet Recruiting

2

Hôpital Privé Jacques Cartier

Massy, France, 91300

Not Yet Recruiting

3

Hôpital Pitié-Salpêtrière

Paris, France, 75013

Not Yet Recruiting

4

Hôpital Bichat

Paris, France, 75018

Not Yet Recruiting

5

Hôpital européen Georges Pompidou

Paris, France, 75908

Not Yet Recruiting

6

Bordeaux University Hospital

Pessac, France, 33604

Actively Recruiting

7

CHR Pontchaillou

Rennes, France, 35033

Not Yet Recruiting

8

CHU de Saint-Etienne

Saint-Etienne, France, 42055

Not Yet Recruiting

9

CHU de Toulouse

Toulouse, France, 35033

Not Yet Recruiting

10

CHU de Nancy

Vandœuvre-lès-Nancy, France, 54511

Not Yet Recruiting

11

Centre Hospitalier Princesse Grace

Monaco, Monaco, 98000

Not Yet Recruiting

Loading map...

Research Team

M

Michel HAÏSSAGUERRE, MD-PhD

A

Aude CATHALA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

Similar Trials

Do 'Known' QT-prolonging Medications Cause Major Adverse Car...

Acquired Long QT

Actively Recruiting

2 locations

Percutaneous or Surgical Repair in Mitral Prolapse and Regur...

Mitral Valve Prolapse

Actively Recruiting

25 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here