Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI): Where we are today

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1 Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI): Where we are today Benjamin C. Eloff, Ph.D. Senior Scientific Program Manager Office of the Chief Scientist, FDA

2 The SAFARI Initiative AF ablation techniques and devices developed and refined rapidly Guidelines, consensus statement, AHRQ review published relying on current state of evidence, and noting limited follow-up data and limited generalizability of data. FDA recognizes similar gaps in data generated in premarket studies as discussed in September 2007 panel meeting FDA proposes a project through CSRC to develop a publicprivate partnership (PPP) to identify and fill known gaps in data April 2009, FDA hosts first workshop for SAFARI ACC, HRS, AdvaMed, CSRC, & FDA joined together to lay groundwork for the structure of the SAFARI partnership

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4 Basic Steps in Developing PPPs with FDA (not comprehensive! not consecutive!) Start with the Public Health Need, SCIENCE! Identify Priorities for multiple stakeholders Identify gaps/avoid duplication e.g. biomarkers: Hold expert workshop, Identify partners etc. Leverage resources/expertise Identify partners: define roles/responsibilities Co-develop: proposals, budgets, timelines etc. Implement joint projects Share data in public domain as quickly as appropriate Some Benefits Industry: Postmarket trial data, Hypothesis generation FDA: Data for guidance development and regulatory mission ACC/HRS: Best Practices, Clinical Data CMS & Payers: Data for reimbursement policy decisions Patients: faster, safer and cheaper medical products!!!!

5 SAFARI Mission To facilitate a national pan-stakeholder collaboration supporting the design, implementation, and maintenance of a logistically feasible registry platform for systematic data collection characterizing the safety and effectiveness of on- and off-label real world atrial fibrillation ablation. The intention of this registry will be to inform the development of reliable knowledge, practice guidelines, and to better inform regulatory processes in relationship to the safety of medical products used in the diagnosis, ablation and subsequent treatment of atrial fibrillation.

6 SAFARI Objectives Establish a transparent, nationwide registry for collecting data related to AF ablation procedures Publicly report the data contained in the registry to inform the public health Specifically, the SAFARI partnership will: 1. Develop a framework for collaboration with participation from multiple stakeholders, resulting in an administrative infrastructure to facilitate joint activities in the study of ablation therapies for AF. 2. Support efforts to bridge the knowledge gaps that exist in the field of AF ablation. 3. Ensure that information resulting from these collaborative efforts is appropriately made available to stakeholders and the public. 4. Inform stakeholders, clinicians, and patients, through joint publications, regulatory guidance documents, workshops, and other educational and outreach efforts, of any potential safety risks associated with AF ablation. 5. Make recommendations on labeling of AF ablation devices, based on available data, and to inform regulatory decision-making. 6. Inform future activities, including clinical trials and the application of ablation therapy to treat AF.

7 Stakeholder Community Industry Payers Government Academia Professional Societies Hospitals Steering Executive Operations Budget Ad hoc Meeting Registry development team Registry implementation team Data quality team Data use & publications team

8 Today s Meeting and Next Steps Establish Steering and modify/implement governance Continue outreach to interested stakeholders Summarize, incorporate, and publish feedback from this meeting Secure funding for pilot registry

9 Thank You Meeting Planning Sana Al-Khatib Muriel Corcoran Ruey Dempsey John Finkle Daniel Frisch Isabelle LeBlanc Kristi Mitchell Kathy Pontzer Jeremy Ruskin Executive Operations Peter Kowey (Co-Chair) Ben Eloff (Co-Chair) Marcia Yaross Hugh Calkins Stephen Hammill Mitchell Krucoff Ellen Pinnow CSRC staff Valarie Morrow Valerie Bailey Eva Hill