title: Planning the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: a Cardiac Safety Research Consortium "Incubator" Think Tank.
abstract: Atrial fibrillation (AF) is a major public health problem in the United States that is associated with increased mortality and morbidity. Of the therapeutic modalities available to treat AF, the use of percutaneous catheter ablation of AF is expanding rapidly. Randomized clinical trials examining the efficacy and safety of AF ablation are currently underway; however, such trials can only partially determine the safety and durability of the effect of the procedure in routine clinical practice, in more complex patients, and over a broader range of techniques and operator experience. These limitations of randomized trials of AF ablation, particularly with regard to safety issues, could be addressed using a synergistically structured national registry, which is the intention of the SAFARI. To facilitate discussions about objectives, challenges, and steps for such a registry, the Cardiac Safety Research Consortium and the Duke Clinical Research Institute, Durham, NC, in collaboration with the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, organized a Think Tank meeting of experts in the field. Other participants included the National Heart, Lung and Blood Institute, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Society of Thoracic Surgeons, the AdvaMed AF working group, and additional industry representatives. The meeting took place on April 27 to 28, 2009, at the US Food and Drug Administration headquarters in Silver Spring, MD. This article summarizes the issues and directions presented and discussed at the meeting.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA. alkha001@mc.duke.edu
authors.forename: Sana M
authors.initials: SM
authors.lastname: Al-Khatib
authors.forename: Hugh
authors.initials: H
authors.lastname: Calkins
authors.forename: Benjamin C
authors.initials: BC
authors.lastname: Eloff
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Packer
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Ellenbogen
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Hammill
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
authors.forename: Richard L
authors.initials: RL
authors.lastname: Page
authors.forename: Eric
authors.initials: E
authors.lastname: Prystowsky
authors.forename: Warren M
authors.initials: WM
authors.lastname: Jackman
authors.forename: William G
authors.initials: WG
authors.lastname: Stevenson
authors.forename: Albert L
authors.initials: AL
authors.lastname: Waldo
authors.forename: David
authors.initials: D
authors.lastname: Wilber
authors.forename: Peter
authors.initials: P
authors.lastname: Kowey
authors.forename: Marcia S
authors.initials: MS
authors.lastname: Yaross
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Mark
authors.forename: James
authors.initials: J
authors.lastname: Reiffel
authors.forename: John K
authors.initials: JK
authors.lastname: Finkle
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.forename: Ellen
authors.initials: E
authors.lastname: Pinnow
authors.forename: Phillip
authors.initials: P
authors.lastname: Sager
authors.forename: Art
authors.initials: A
authors.lastname: Sedrakyan
authors.forename: Daniel
authors.initials: D
authors.lastname: Canos
authors.forename: Thomas
authors.initials: T
authors.lastname: Gross
authors.forename: Elise
authors.initials: E
authors.lastname: Berliner
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D001281:Atrial Fibrillation / Q000401:mortality / Q000601:surgery*; D017115:Catheter Ablation; D019091:Critical Pathways; D005260:Female; D006801:Humans; D007400:Interprofessional Relations; D008297:Male; D012042:Registries; D017751:Safety Management; D014481:United States