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.

  • Organizations

    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 Investigators

    Heidi Hinrichs, MS, Abbott, Kevin Mitchell, BIOTRONIK, Inc., Rich Dujmovic, MSEM, Boston Scientific, Darrell Johnson, MBA, Medtronic, and David Slotwiner, MD, Weill Cornell Medical College

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NESTcc's Test-Case study protocol on synthetic mid-urethral slings for stress urinary incontinence in women is open for public comment through June 12. More: bit.ly/2RM654T pic.twitter.com/fk4ore1Kmg 1 day ago

NESTcc is requesting public comments on the study protocol of our Test-Case focused on synthetic mid-urethral slings for stress urinary incontinence in women. The comment period is open until June 12. More: bit.ly/2RM654T pic.twitter.com/5owFLFq1Fl 1 week ago

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