Using Standard 12-lead ECG to Identify Patients Eligible for Subcutaneous Defibrillator Implantation

What this Trial Is About

Researchers are investigating the use of a standard 12-lead electrocardiogram ECG to predict which patients might be eligible for implantation of the Boston Scientific Inc. subcutaneous implantable cardioverter defibrillator S-ICD. The S-ICD is designed to prevent and treat sudden cardiac arrest by detecting rapid ventricular arrhythmias through signals from a fully subcutaneous system, avoiding the risks linked to traditional transvenous devices. The study aims to find electrocardiographic markers on a 12-lead ECG that could eliminate the need for the current 3-lead screening ECG prior to implantation. Participants who meet eligibility criteria will be invited by their cardiologist during a routine consultation and asked to provide oral consent. They will then be grouped based on their screening results into those who screen positive and those who screen negative for S-ICD eligibility. The study involves analyzing the 12-lead ECG scans using advanced deep learning methods to accurately predict screening outcomes. No additional treatment or follow-up is planned as part of the study. During the study, clinical data will be securely collected and analyzed. Researchers will assess specific ECG features, including the ratio of the R wave size related to ventricular depolarization and the amplitude of the T wave linked to ventricular repolarization over an 18-month period. This evaluation will help determine how well the 12-lead ECG can predict the patients suitability for the subcutaneous defibrillator without requiring additional screening procedures.

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