Pacing Alternate Sites using SelectSecure (PASSES Study): To assess the ease of implant in targeting alternate pacing sites with a catheter delivered lead compared with the stylet lead.

Medical evidence suggests that the right ventricular (RV) apex and right atrial (RA) appendage may be suboptimal lead locations for providing chronically effective pacing therapy. Over recent years alternate pacing sites, or ‘selective sites’, have been proposed and evaluated. These are sites other than the traditional Atrial Appendage and RV Apex pacing. Such sites are suggested to reduce ventricular dysfunction, atrial arrhythmias, and influence morbidity resulting from asynchronous Left Ventricular (LV) activation associated with traditional RV apex pacing. The Medtronic SelectSecure Deflectable Catheter Delivered Lead System was developed to assist physicians implanting a pacing lead in an RV or RA selective site such as the RVOT or the ventricular septum, the Bachman bundle area or the atrial septum. PASSES is a prospective, randomised, multicenter clinical trial to assess the ease of implant in targeting alternate pacing sites with a catheter delivered lead compared with the stylet lead. The chronic aspect of the study will enable analysis of the long-term lead performance and will provide a first estimation of economic benefits for pacing with a new therapy and tool. This study compares the novel approach of new therapy of pacing selective sites with new tools to the traditional pacing therapy and tools. During the follow-up period information will be collected on lead performance (electrical and clinical data), adverse events, health care utilization, and progression of HF and AF. This is expected to provide information on the long-term lead performance, and the clinical and economic benefits for implanting alternate sites with the SelectSecure lead.