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
Sana M Al-KhatibMitchell W Krucoff

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...Continue Reading

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Citations

Mar 4, 2010·Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing·Ann C Garlitski, N A Mark Estes
Mar 15, 2011·Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing·N A Mark EstesAfshin Ehsan
Aug 23, 2011·Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing·Sana M Al-Khatib
Mar 6, 2012·Europace : European Pacing, Arrhythmias, and Cardiac Electrophysiology : Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology·Hugh CalkinsDavid Wilber
Apr 9, 2011·Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing·Pasquale SantangeliAndrea Natale
May 20, 2014·The American Journal of Cardiology·Peter Russell Kowey, William Clifford Roberts
Aug 7, 2012·Heart Rhythm : the Official Journal of the Heart Rhythm Society·Pasquale SantangeliAndrea Natale
Jun 15, 2016·American Heart Journal·J Rick TurnerUNKNOWN Cardiac Safety Research Consortium
Mar 3, 2018·Circulation Research·Jordi HeijmanStanley Nattel

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