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  • 1. Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Pilot Study Douglas L. Packer, Kerry L. Lee, Daniel B. Mark, Kristi H. Monahan, Kathleen L. Hoffmann, Gail E. Hafley, Jeanne E. Poole, Tristram D. Bahnson, David J. Bradley, Richard Robb, Maryam Rettmann, David R. Holmes III, William Stevenson, John D. Hummel, Steven J. Bailin, John D. Day, Anil K. Bhandari, Francis Marchlinski, Neil Kay, Hugh Calkins, David J. Wilber ACC Atlanta March 15, 2010

2. Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation: Results of the CABANA Pilot Study Research Relationships (DLP) with Biosense, Acuson, Siemens, Cryocath, EPT, St. Jude, Cardiofocus, Symphony, Prorhythm, NIH Royalties from IP licensed by St. Jude Medical Unpaid consulting relationships: Medtronic, Boston Scientific, St. Jude, Biosense, Siemens, Cryocath Other information available from Mayo Communications Funded by St. Jude Medical Foundation, St. Paul, Minnesota 3. Disclosures The CABANA Pilot study was funded by St. Jude Medical Foundation.Dr. D. Packer in the past 12 months has provided consulting services for Biosense Webster, Inc., Boston Scientific, CyberHeart, Medtronic, Inc., nContact, Sanofi-Aventis, St. Jude Medical, and Toray Industries.Dr. Packer received no personal compensation for these consulting activities.Dr. Packer receives research funding from the NIH, Medtronic, Inc., CryoCath, Siemens AG, EP Limited, Minnesota Partnership for Biotechnology and Medical Genomics/ University of Minnesota, Biosense Webster, Inc. and Boston Scientific. Mayo Clinic and Drs. D. Packer and R. Robb have a financial interest in mapping technology that may have been used at some of the 10 centers participating in this pilot research.In accordance with the Bayh-Dole Act, this technology has been licensed to St. Jude Medical, and Mayo Clinic and Drs. Packer and Robb have received annual royalties greater than $10,000, the federal threshold for significant financial interest. Mayo Clinic and Dr. R. Robb have a financial interest in Analyze-AVW technology that was used to analyze some of the heart images in this research.In accordance with the Bayh-Dole Act, this technology has been licensed to commercial entities, and both Mayo Clinic and Dr. Robb have received royalties greater than $10,000, the federal threshold for significant financial interest.In addition, Mayo Clinic holds an equity position in the company to which the AVW technology has been licensed. 4. Purpose of CABANA Pilot Study

  • Determine the freedom from AF with ablation vs drug therapy in patients with more problematic AF and accompanying co-morbidities
  • Test the feasibility of a long-term pivotal trial for assessing mortality, stroke, hospitalization and cost outcomes

CABANA Pilot Study; ACC 2010 5. Design of the CABANA Pilot Study

  • 2 paroxysmal AF episodes ( 1 hour) over 4 mos or> 1 persistent AF episode (>1 week)
  • 65 yr of age, or 5.0 cm (Vol In 40 cc/m 2 )
    • EF 35 %
  • Eligible for ablation and 2 rhythm control and/or 3 rate control drugs

CABANA Pilot Study; ACC 2010 Inclusion Criteria Atrial fibrillation Warranting Therapy > 65 yr of age or