Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study

Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia

Ventricular Defibrillation, Extravascular

STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices. The study is intended to inform the final device design which will be further evaluated in traditional feasibility and /or pivotal clinical investigations. The primary safety objective is to characterize safety of the EV-ICD Lead through 3 months post-implant. The primary performance objective is to characterize sensing and conversion of induced VF with the EV-ICD Lead up to 3 months post-implant.

The primary safety endpoint is incidence of Adverse Device Effects (ADEs). The primary performance endpoint is induced VF conversion success up to 3 months post-implant. Secondary endpoints include defibrillation metrics (i.e., lowest Conversion Energy (J), ability to automatically sense and detect ventricular arrhythmias, detection time and time-to-therapy) and pacing metrics (ventricular capture threshold (V), pacing impedance (ohms), R-wave amplitude (mV), and extracardiac pacing sensation level). Up to 30 eligible Subjects undergoing a pectoral transvenous ICD procedure (de novo or replacement) will receive an EV-ICD Lead connected to a commercially available ICD in a left mid-axillary or left pectoral pocket. The EV-ICD System will be tested in the intended implant location to determine the lowest defibrillation energy. Subjects will remain in the hospital overnight (at a minimum), prior to discharge. Except during testing, the EV-ICD System will remain programmed to monitor only (therapy OFF) to detect and store ventricular arrhythmias over the follow-up period. A concomitantly implanted transvenous ICD (TV-ICD) system will provide any necessary ICD therapy. Non-therapy EV-ICD programming parameters will match the TV-ICD to the extent possible to facilitate recording of matched stored electrograms. Follow-up visits are planned at pre-discharge, 2 weeks, 1 month, 2 months, and 3 months. VF conversion testing will occur prior to lead removal in order to test subchronic defibrillation effectiveness with a submaximal energy shock in standard and/or reverse polarity. At the Lead Removal Follow Up, the EV-ICD System will be explanted and the TV-ICD System left in place. A final follow-up will occur one month after EV-ICD Lead explant to assess any post-explant adverse events prior to study exit.

Paraguay