Study concept and design: Reddy, Buchbinder, Swarup, Gordon, Holmes.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Reddy, Holmes.
Critical revision of the manuscript for important intellectual content: Sievert, Halperin, Doshi, Buchbinder, Neuzil, Huber, Whisenant, Kar, Swarup, Gordon, Holmes.
Statistical analysis: Reddy.
Obtained funding: Holmes.
Administrative, technical, or material support: Reddy, Huber, Gordon, Holmes.
Study supervision: Reddy, Sievert, Doshi, Buchbinder, Neuzil, Whisenant, Kar, Holmes.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Reddy reported having received research grant support and consultant fees from Boston Scientific. Dr Sievert reported having received research grant support and consultant fees from Boston Scientific. Dr Doshi reported having received research grant support and consultant fees from Boston Scientific. Dr Buchbinder reported having received research grant support and consultant fees from Boston Scientific. Dr Neuzil reported having received research grant support from Boston Scientific. Dr Whisenant reported having received research grant support and consultant fees from Boston Scientific. Dr Kar reported having received research grant support and consultant fees from Boston Scientific. Dr Swarup reported having received research grant support and consultant fees from Boston Scientific. Ms Gordon reported being an employee of Boston Scientific. Dr Holmes reported having received research grant support from Boston Scientific. Also, the LAA closure technology has been licensed to Boston Scientific, and both Mayo Clinic and Dr Holmes have contractual rights to receive future royalties from this license. But to date, no royalties have been received. No other disclosures were reported.
Funding/Support: This study was funded by the manufacturer of the device, Atritech (now owned by Boston Scientific), which provided the LAA closure device used in this trial.
Role of the Funder/Sponsor: The sponsor designed the study protocol in collaboration with the US Food and Drug Administration (FDA) and participating investigators. The study was intended to support market approval of the LAA closure device, which is manufactured by the sponsor. The sponsor had the overall responsibility for the conduct of the study, including assurance that the study met the regulatory requirements of the FDA. The sponsor’s general duties consisted of submitting the Investigational Device Exemption application to the FDA, obtaining FDA and institutional review board approvals before shipping the devices, approving the investigators, ensuring proper clinical site monitoring, and ensuring patient informed consent was obtained. The sponsor was responsible for providing quality data that satisfied federal regulations, informing proper authorities of serious unanticipated adverse events and deviations from the protocol, training all participating investigators on the study device and protocol, and monitoring the study for data integrity throughout the duration of the investigation. In addition, the sponsor was responsible for data collection and basic data analysis. The sponsor participated in additional data analysis, data interpretation, and the drafting of the manuscript in conjunction with the principal and other investigators, as well as the decision to submit the manuscript for publication.
The PROTECT AF Trial Investigators:Steering Committee: David R. Holmes, Mayo Clinic College of Medicine, Rochester, Minnesota (P.I.); Maurice Buchbinder, Foundation for Cardiovascular Medicine, La Jolla, California; Larry Chinitz, New York University Medical Center, New York; Pam Douglas, Duke COResearch Core Laboratory, Raleigh, North Carolina; John Gurley, University of Kentucky, Lexington; Vivek Y. Reddy, Mount Sinai School of Medicine, New York; Peter Sick, Krankenhaus der Barmherzigen Bruder, Regensburg, Germany; Zoltan G. Turi, Cooper Hospital, Camden, New Jersey. Data and Safety Monitoring Board: Stephen T. Hustead, DO, Metropolitan Cardiology Consultants, Fridley, Minnesota (Chair); Richard W. Asinger, MD, Hennepin County Medical Center, Minneapolis, Minnesota; Wendy Shear, MD, North Memorial Heart and Vascular Institute, Minneapolis; Chris Pulling, MS, NAMSA, Minneapolis (Statistician). Clinical Events Committee: Brian Lew, MD, Minnesota Heart Clinic, Minneapolis (Chair); D. Anthony Plucinski, MD, Hennepin County Medical Center, Minneapolis; Eve Rogers, MD, Columbus, Ohio. Clinical Investigators (Site [No. of Enrollments]): Europe: Petr Neuzil (Na Homolce Hospital, Prague, Czech Republic ); Horst Sievert (Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany ); Sven Mobius-Winkler (Herzzentrum Leipzig, Leipzig, Germany ); Peter Sick (Krankenhaus der Barmherzigen Bruder, Regensburg, Germany ); United States: Kelly Tucker (Orange County Heart, Orange County, California ); Shephal Doshi (Pacific Heart Institute/St John’s Health Center, Santa Monica, California ); Vijay Swarup, Marwan Bahu (Arizona Arrhythmia Consultants, Scottsdale ); Ramon Quesada (Baptist Hospital of Miami, Miami, Florida ); Kenneth Huber (St Luke’s Hospital, Kansas City, Missouri ); Vivek Reddy (Massachusetts General Hospital, Boston ); Maurice Buchbinder (Foundation for Cardiovascular Research, La Jolla, California ); Brian Whisenant (Intermountain Medical Center, Murray, Utah ); Steven Almany (William Beaumont Hospital, Royal Oak, Michigan ); David R. Holmes (Mayo Clinic, Rochester ); Robert M. Siegel, Ashok Garg (Advanced Cardiac Specialists, Gilbert, Arizona ); Gregory Mishkel (PERC/St John’s Hospital, Springfield, Illinois ); Stephen Ramee (Ochsner Clinic, New Orleans, Louisiana ); Saibal Kar (Cedars-Sinai Medical Center, Los Angeles, California ); Brijeshwar Maini (Moffitt Heart and Vascular Group, Wormleysburg, Pennsylvania ); Ray Matthews, Steven Burstein (Los Angeles Cardiology Associates, Los Angeles ); Rodney Horton (Texas Cardiac Arrhythmia Research, Austin ); Paul Mahoney, John Onufer (Sentara Norfolk General Hospital, Norfolk, Virginia ); Kenneth Baran, Stuart Adler (St Paul Heart Clinic, St Paul, Minnesota ); Kimberly Skelding (Geisinger Medical Center, Danville, Pennsylvania ); John Gurley (University of Kentucky, Lexington ); Miland Shah (Marshfield Clinic, Marshfield, Wisconsin ); Steven J. Yakubov (Riverside Methodist Hospital, Columbus ); Angel Leon (Crawford Long Hospital, Atlanta, Georgia ); Peter C. Block (Emory University School of Medicine, Atlanta ); Peter Fail, Richard Abben (Terrebonne General Medical Center, Houma, Louisiana ); Mark Reisman (Swedish Cardiovascular Research, Seattle, Washington ); Gery Tomassoni (Lexington Cardiology at Central Baptist, Lexington ); Vishwajeth Bhoopalam (Nebraska Heart Institute, Lincoln ); William Anderson (UPMC [Presbyterian University Hospital], Pittsburgh, Pennsylvania ); Robert A. Pickett, Douglas Wolfe (Baptist Medical Center, Jackson, Mississippi ); Reginald Low (UC Davis Medical Center, Sacramento, California ); Ted Feldman, Michael Sallinger (Evanston Northwestern Healthcare, Evanston, Illinois ); James Irwin (Bay Heart Group, Tampa, Florida ); John Lopez, Bradley Knight (University of Chicago Medical Center, Chicago, Illinois ); Scott Lim (University of Virginia School of Medicine, Charlottesville ); Larry Chinitz (New York University Medical Center, New York ); Mehdi Razavi (St Luke’s Episcopal Hospital, Houston, Texas ); David Wilbur, Ferdinand Leya (Loyola University Medical Center, Maywood, Illinois ); Zoltan G. Turi (Cooper Hospital, Camden, New Jersey ); Bryan Raybuck (INOVA Research Center, Falls Church, Virginia ); Ron Waksman, Horst Sievert (Washington Hospital Center, Washington, DC ); Steven Kalbfleisch (Ohio State University, Columbus ); Michael Mooney (Abbott Northwestern Hospital, Minneapolis ); William Gray (Columbia University Medical Center, New York ); Geoffrey Kunz (New Mexico Heart, Albuquerque ); Malcolm Foster (Baptist Heart Institute, Knoxville, Tennessee ); Eric Good (University of Michigan, Ann Arbor ); Murat Tuzcu (Cleveland Clinic Foundation, Cleveland, Ohio ); Fred St. Goar (El Camino Hospital, Mountain View, California ); Richard Josephson (Summa Health System, Akron, Ohio ); W. Carl Jacobs (Piedmont Hospital, Atlanta ); Rajesh Dave (Harrisburg Hospital, Harrisburg, Pennsylvania ); John Young (Lindner Clinical Trial Center, Cincinnati, Ohio ); David Lasorda (Allegheny General Hospital, Pittsburgh ).
Correction: This article was corrected online February 4, 2015.