Electrophysiology Predictable and Sustainable Implementation of National Registries: EP PASSION Li Wang, PhD, MBA, MS, Daniel Canos, PhD, MPH, Hetal Patel, MS, Jessica Paulsen, BS, Kimberly Selzman, MD, Benjamin Eloff, PhD, Danica Marinac-Dabic, MD, PhD, MMSc, FISPE. Office of Surveillance and Biometrics & Office of Device Evaluation, Center for Devices and Radiological Health U.S. Food and Drug Administration, Silver Spring, MD. 20903 The Regulatory Gap Traditional Post-Approval Inefficiencies • Stand-Alone Study • Pace and Enrollment Difficulty • Prolonged Completion Time • Next Generation on market before “Lessons Learned” Traditional Post-Market Study Cost • ~$10 million in traditional PAS studies • Potential 40-60% savings with registry based surveillance EP PASSION Objectives EP PASSION is focused on implantable cardioverter defibrillator system leads and pulse generators and cardiac resynchronization therapy left heart leads. A RWE- based approach can streamline post-approval studies by: • Reducing Cost • Reduce time to enrollment completion • Reduce loss to follow-up • Provide timely answers to post-market questions Objective 1: • Transition long-term direction patient follow-up assessment in current post- approval studies (PAS) towards a real world evidence approach (RWE). Objective 2: • Develop sustainable mechanism to collect long-term chronic performance of new and substantially modified pacing and defibrillation leads. EP PASSION Components Phase II: ID Phase III: Develop New/Modify Phase IV: Develop Linked Approach EP PASSION Phased Approach EP PASSION Post-Approval Study Transition Extant Registry/EHR Claims Remote Monitoring Implant & Periprocedural Data Annual Follow-Up Annual Follow-Up Traditional PAS Transition of Ongoing PAS ~10 Years <10 Years Novel RWE PAS <10 Years EP PASSION Influence The shift towards RWE in the EP field has already begun…. • FDA recently approved the Boston Scientific S-ICD Post-Approval Study with no pre-market data. The powered, hypothesis-driven study incorporates the ACC NCDR registry, Boston Scientific’s LATITUDE NXT Patient Management System, CMS/Truven claims, and the National Death Index. EP PASSION Partners EP PASSION Timeline