Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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