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Search / Trial NCT04921501

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jun 4, 2021

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Signal Averaging Ecg Cardiac Electrophysiology

ClinConnect Summary

This clinical trial is studying a new way to measure heart activity using a special tool called High Density Electrocardiography (ECG-HD). Unlike the standard ECG that uses 12 leads to detect heart signals, this new method uses 128 leads, which may provide a more detailed picture of how the heart is functioning. This is particularly important for patients who have serious heart rhythm problems, known as ventricular arrhythmias, which can sometimes lead to sudden cardiac events.

To participate in this study, you must be at least 14 years old and have been diagnosed with severe heart rhythm issues or be at high risk for them. This could include having a history of fainting, a family history of sudden death, or certain heart conditions. If you join the trial, you can expect to undergo tests that will help the researchers compare the new ECG method with traditional techniques. It's important to know that pregnant or nursing women cannot participate, and the study is currently looking for volunteers at Bordeaux University Hospital.

Gender

ALL

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.

About University Hospital, Bordeaux

The University Hospital of Bordeaux is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the institution integrates cutting-edge scientific inquiry with patient care, fostering an environment that encourages collaboration among multidisciplinary teams. With a commitment to improving treatment outcomes and enhancing patient safety, the University Hospital of Bordeaux plays a pivotal role in the development of new therapies and medical technologies, contributing significantly to the global medical community.

Locations

Paris, , France

Paris, , France

Saint Etienne, , France

Vandoeuvre Les Nancy, , France

Paris, , France

Monaco, , Monaco

Pessac, , France

Clermont Ferrand, , France

Massy, , France

Rennes, , France

Toulouse, , France

Patients applied

0 patients applied

Trial Officials

Michel HAÏSSAGUERRE, MD-PhD

Principal Investigator

University Hospital, Bordeaux

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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