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

Sana M. Al-Khatib, Hugh Calkins, Benjamin C. Eloff, Douglas L. Packer, Kenneth A. Ellenbogen, Stephen C. Hammill, Andrea Natale, Richard L. Page, Eric Prystowsky, Warren M. Jackman, William G. Stevenson, Albert L. Waldo, David Wilber, Peter Kowey, Marcia S. Yaross, Daniel B. Mark, James Reiffel, John K. Finkle, Danica Marinac-Dabic, Ellen PinnowPhillip Sager, Art Sedrakyan, Daniel Canos, Thomas Gross, Elise Berliner, Mitchell W. Krucoff

Research output: Contribution to journalReview article

18 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)17-24.e1
JournalAmerican heart journal
Volume159
Issue number1
DOIs
StatePublished - Jan 2010

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Al-Khatib, S. M., Calkins, H., Eloff, B. C., Packer, D. L., Ellenbogen, K. A., Hammill, S. C., Natale, A., Page, R. L., Prystowsky, E., Jackman, W. M., Stevenson, W. G., Waldo, A. L., Wilber, D., Kowey, P., Yaross, M. S., Mark, D. B., Reiffel, J., Finkle, J. K., Marinac-Dabic, D., ... Krucoff, M. W. (2010). 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. American heart journal, 159(1), 17-24.e1. https://doi.org/10.1016/j.ahj.2009.10.018