Identifying Electrocardiographic Markers to Determine Eligibility for the Implantation of a Subcutaneous Defibrillator.

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.

NCT Number	NCT07157449
Lead Sponsor	Nantes University Hospital
Conditions	Defibrillator, ECG
Enrollment	1,000 participants
Start Date	2026-01-27
Primary Completion	2026-10-31 (estimated)
Study Completion	2027-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-24