Evaluating heart activity using advanced ECG technology
Evaluation of Electrocardiographic Measurements by High Density Electrode ECG
This study is testing a new heart monitoring technology to see if it can better detect heart problems in patients with serious arrhythmias compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 11 sites (Clermont-Ferrand and 10 other locations) |
| Trial ID | NCT04921501 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of high-density electrocardiography (HD ECG) with 128 body surface leads compared to conventional 12-lead ECG in detecting cardiac electrical activity. The aim is to improve sensitivity in measuring global or regional cardiac activity, particularly in patients with severe ventricular arrhythmias. By capturing more comprehensive data, the study seeks to provide additional clinical insights that could enhance patient management and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with documented severe ventricular arrhythmias or those at high risk for sudden cardiac events, such as those with low ejection fraction or a history of ventricular tachycardia.
Not a fit: Patients under 14 years old or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better detection and management of ventricular arrhythmias, potentially improving patient outcomes.
How similar studies have performed: While the use of high-density ECG is a novel approach, similar studies have shown promise in enhancing cardiac monitoring and diagnostics.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clermont-Ferrand and 10 other locations
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- Hôpital Privé Jacques Cartier — Massy, France (Not_yet_recruiting)
- Hôpital Pitié-Salpêtrière — Paris, France (Not_yet_recruiting)
- Hôpital Bichat — Paris, France (Not_yet_recruiting)
- Hôpital européen Georges Pompidou — Paris, France (Not_yet_recruiting)
- Bordeaux University Hospital — Pessac, France (Recruiting)
- CHR Pontchaillou — Rennes, France (Not_yet_recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Not_yet_recruiting)
- CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
- CHU de Nancy — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)
- Centre Hospitalier Princesse Grace — Monaco, Monaco (Not_yet_recruiting)
Study contacts
- Principal investigator: Michel HAÏSSAGUERRE, MD-PhD — University Hospital, Bordeaux
- Study coordinator: Michel HAÏSSAGUERRE, MD-PhD
- Email: michel.haissaguerre@chu-bordeaux.fr
- Phone: (0)5 57 65 64 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.