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NCT07157449
Identifying Electrocardiographic Markers to Determine Eligibility for the Implantation of a Subcutaneous Defibrillator.
Conditions: Defibrillator, ECG
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Nantes University Hospital
Location: CHU de Nantes Nantes Nantes
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 Criteria
Inclusion Criteria :
* 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
Exclusion Criteria :
* Patients receiving cardiac stimulation
* Patient taking part in a therapeutic trial which may interfere with the results of the research
* Patients under guardianship.
Source: ClinicalTrials.gov (NCT07157449). StuddyBuddy aggregates publicly available trial information.