Study concept and design: Morillo, Verma, Connolly, Kuck, Nair, Champagne, Sterns, Natale.
Acquisition of data: Morillo, Verma, Kuck, Nair, Champagne, Sterns, Natale.
Analysis and Interpretation of Data: Morillo, Connolly, Healey, Beresh, Natale.
Drafting of the manuscript: Morillo, Verma, Connolly, Healey, Natale.
Critical revision of the manuscript for important intellectual content: Morillo, Verma, Connolly, Kuck, Nair, Champagne, Sterns, Beresh, Healey.
Statistical Analysis: Morillo, Verma, Connolly, Natale.
Administrative technical or material support: Morillo, Connolly, Beresh.
Study Supervision: Morillo, Connolly, Beresh, Natale.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Morillo reported receiving grants from Biosense Webster, Boston Scientific, Medtronic, St Jude Medical and consulting fees from Biosense Webster, Boston Scientific, Biotronik, Boehringer Ingelheim, Merck. Dr Verma reported receiving grants and consulting fees from St Jude Medical, Medtronic, and Boerhinger Ingelheim. Dr Kuck reported receiving grants and consulting fees from Biosense Webster and St Jude Medical. Dr Healey reported receiving grants from St Jude Medical and Boston Scientific and consulting fees from St Jude Medical, Medtronic, and Boehringer Ingelheim. Dr Natale reported receiving grants and consulting fees from Biosense Webster and St Jude Medical. Drs Connolly, Nair, Champagne, and Sterns reported no disclosures.
Funding/Support: This study was supported by an unrestricted research grant from Biosense Webster (Dr Morillo) and the Population Health Research Institute (PHRI), sponsored and supported by PHRI at McMaster University.
Role of the Sponsors: The study was designed by the sponsor (PHRI) and coprincipal investigators (Drs Morillo and Natale) in addition with the steering committee (Drs Verma, Connolly, Kuck, Nair, Sterns, Healey, Wilber, MD, Cardiovascular Institute, Department of Medicine, Loyola University Medical Center, and Callans, MD, Hospital of the University of Pennsylvania, Philadelphia). Biosense Webster had no role in the design or analysis of the data. The PHRI under the leadership of the principal investigator Dr Morillo had the overall responsibility for the conduct of the study, including assurance that the study met the regulatory requirements of the US Food and Drug Administration (FDA) and EUDRA-CT. The sponsor’s general duties consisted of submitting the Investigational Device Exemption application to the FDA, obtaining FDA and institutional review board approvals, approvals of the investigators, ensuring proper clinical site monitoring and ensuring patient informed consent was obtained. The Population Health Research Institute was responsible for providing quality data that satisfied federal and national regulations and informing proper authorities of serious unanticipated adverse events and deviations from the protocol and for monitoring all participating investigators on the study protocol and monitoring the study for data integrity throughout the duration of the investigation. In addition, the PHRI was responsible for data collection and all data analysis, interpretation and drafting of the manuscript in conjunction with the principal investigators and steering committee members, as well as the decision to submit the manuscript for publication.
Statistical Analysis: All efficacy and primary safety results and conclusions presented in this manuscript were conducted and reviewed by the PHRI Senior Biostatistician and Director of the Biostatistics Division, Janice Pogue, PhD. All analyses were conducted by Purnima RaoMelacini, Biostatistician at PHRI. All analyses were reviewed and interpreted in conjunction by Drs Morillo, Connolly, Natale, and Pogue.
The RAAFT-2 Investigators: Coprincipal Investigators: Drs Morillo and Natale.
Clinical Centers: Hamilton Health Sciences General Division, Hamilton, Ontario, Canada: C.A. Morillo (principal investigator), S. J. Connolly, J. S. Healey, S. Divakaramenon, and G. M. Nair; Victoria Cardiac Arrhythmia Trials Inc,Victoria, British Columbia, Canada: L. D. Sterns, R. L. Leather, and P. G. Novak; Southlake Regional, Newmarket, Ontario, Canada: A. Verma, Y. Khaykin, and Z. Wulffhart; London Health Sciences Centre, London, Ontario: A. C. Skanes, L. J. Gula, and G. J. Klein; Montreal Heart Institute, Montreal, Quebec, Canada: L. Macle and P. G. Guerra; Sunnybrook Medical Center, Toronto, Ontario: E. Crystal and I. Lashevsky; Universite de Laval, Quebec: J. Champagne, G. O'Hara, and J.-F. Sarrazin; McGill University, Montreal, Ontario: V. Essebag and T. Hadjis; Institute for Clinical and Experimental Medicine, Czech Republic: J. Kautzner and R. Cihak; Charles University, Czech Republic: D. Wichterle, S. Havranek, and J. Simek; Askelpois Klinik St Georg, Germany: K. H. Kuck; Abteilung Rhythmologie, Germany: T. Arentz and C. Herrera Siklódy; University Hospital Eppendorf, Germany: T. Rostock; F. Miulli Hospital, Italy: M. Grimaldi and G. Katsouras; St Davis Medical Center, Austin, Texas: A. Natale (principal investigator); and Austin Heart, Austin, Texas: D. R. Tschopp and J. N. Whitehill.
Additional Contributions: We thank Andrew Krahn, MD, FRCPC, Department of Medicine and Cardiology Division, University of British Columbia, for chairing the data and safety monitoring board committee. We also thank the following affiliates from Biosense Webster, who attended all steering committee and investigator meetings and provided guidance in the design and execution of this study: Marcia Yaross, PhD, and Brenda Aker. Dr Krahn received no compensation for his contribution.
Correction: This article was corrected on February 18, 2014, to include the Author Affilications.