Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION)

Overview: The Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION) aims to develop a sustainable mechanism to collect long-term performance across the Total Product Life Cycle (TPLC) of new and substantially modified cardiovascular devices (particularly pacing and defibrillation leads). EP PASSION is a demonstration project for new and substantially modified pacing and defibrillation leads that leverages extant data including potential use of administrative claims, electronic health records, available registries, and remote monitoring and periodic patient contact.

Impact for NESTcc: The use of Real-World Data (RWD) seeks to capture a larger, more representative assessment of device performance while increasing efficiency and lowering cost. It is the aim of the effort to reduce the time and cost of generating the types of evidence used to support the marketing authorization of FDA regulated products and to meet post-market study reporting requirements. The project will transition long-term direct patient follow-up assessment in post-approval studies (PAS) toward a Real-World Evidence (RWE) approach by potential use of administrative claims, electronic health records, available registries, and remote monitoring and periodic patient contact.

Organization(s): Abbott; American College Cardiology (ACC); BIOTRONIK, Inc.; Boston Scientific; Duke; Heart Rhythm Society (HRS); LivaNova (Sorin); Medtronic; U.S. Food and Drug Administration (FDA); Yale

Principal Investigator(s): Heidi Hinrichs, MS (Abbott); Kevin Mitchell (BIOTRONIK, Inc.); Rich Dujmovic, MSEM (Boston Scientific); Darrell Johnson, MBA (Medtronic); David Slotwiner, MD (Heart Rhythm Society)