George H Crossley, Prashanthan Sanders, Bert Hansky, Paolo De Filippo, Maully J Shah, Morio Shoda, Surinder Kaur Khelae, Travis D Richardson, François Philippon, John S Zakaib, Hung-Fat Tse, Darius P Sholevar, Christoph Stellbrink, Rajeev K Pathak, Goran Milašinović, Jason S Chinitz, Bernice Tsang, Michael B West, Brian M Ramza, Xuebin Han, Babak Bozorgnia, Roberto Carta, Tessa Geelen, Adam K Himes, Megan L Platner, Amy E Thompson, Pamela K Mason
BACKGROUND: Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure defibrillation lead is a novel, small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform. OBJECTIVE: This trial assessed safety and efficacy of the OmniaSecure defibrillation lead. METHODS: The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator, all of whom received the study lead...
May 17, 2024: Heart Rhythm: the Official Journal of the Heart Rhythm Society