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Identifying Electrocardiographic Markers on a Standard 12-lead ECG to Determine Which Patients Are Eligible for the Implantation of a Subcutaneous Defibrillator.

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The S-ICD defibrillator developed by Boston Scientific Inc. is a fully subcutaneous automatic defibrillation system that prevents and treats sudden cardiac arrest. The subcutaneous system offers the advantage of avoiding the risks associated with transvenous access, limiting serious infections and lead failures. The detection system is based on the identification of rapid ventricular arrhythmias using one of three bipolar vectors defined by the subcutaneous lead (distal and median electrode) and the generator. However, before implanting the device in a patient, it is essential to carry out a screening procedure to ensure that the patient's QRS signal amplitude is sufficient to be detected by the S-ICD. This screening procedure is carried out by recording a specific three-lead electrocardiogram (ECG), which represents the three bipolar vectors of the S-ICD. The aim of this research is to show that the recording of a standard 12-lead ECG can be sufficient to predict the eligibility of patients for S-ICD implantation. More specifically, it aims to identify electrocardiographic markers on a standard 12D-ECG that can be used to determine which patients may benefit from implantation of a subcutaneous defibrillator, thereby eliminating the need for a 3-lead screening ECG. The developments that will be carried out will be based on the development of signal analysis algorithms and decision support using artificial intelligence.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient undergoing cardiology consultation, whatever the pathology

• Patient over 18 years of age

• Patient having been informed and having given their oral non-opposition

• Patient and relatives affiliated to a social security scheme

Locations
Other Locations
France
CHU de Nantes
RECRUITING
Nantes
Contact Information
Primary
Vincent Probst, PU-PH
vincent.probst@chu-nantes.fr
02 40 16 56 99
Backup
Probst
bp-prom-regl@chu-nantes.fr
Time Frame
Start Date: 2026-01-27
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 1000
Treatments
Identifying electrocardiographic markers on a 12-lead ECG
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov