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Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial FibrillationThe CABANA Randomized Clinical Trial

Educational Objective
To understand the effect of catheter ablation, compared with medical therapy, on quality of life in patients with symptomatic atrial fibrillation.
1 Credit CME
Key Points

Question  What is the effect of catheter ablation, compared with medical therapy, on quality of life in patients with symptomatic atrial fibrillation?

Findings  In this randomized trial of 2204 patients with atrial fibrillation, catheter ablation, compared with conventional medical therapy, significantly improved quality of life at 1 year as measured by the Atrial Fibrillation Effect on Quality of Life score (mean between-group difference, 5.2 points; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory frequency score (mean between-group difference, −1.7 points; patient-level clinically important difference, ≤−1.6 points) and severity score (mean between-group difference, −1.5 points; patient-level clinically important difference, ≤−1.3 points).

Meaning  In patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months.

Abstract

Importance  Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain.

Objective  To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF.

Design, Setting, and Participants  An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017.

Interventions  Pulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096).

Main Outcomes and Measures  Prespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, ≤−1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, ≤−1.3 points).

Results  Among 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P < .001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, −1.7 points [95% CI, −2.3 to −1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, −1.5 points [95% CI, −2.0 to −1.1]; P < .001).

Conclusions and Relevance  Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation.

Trial Registration  ClinicalTrials.gov Identifier: NCT00911508

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Article Information

Accepted for Publication: February 14, 2019.

Corresponding Author: Daniel B. Mark, MD, MPH, Director, Outcomes Research, Duke Clinical Research Institute, 2400 Pratt St, Room 0311, Durham, NC 27705 (daniel.mark@duke.edu).

Published Online: March 15, 2019. doi:10.1001/jama.2019.0692

Correction: This article was corrected on June 18, 2019, to correct an error in the Results section that stated that a higher Atrial Fibrillation Effect on Quality of Life score indicates a higher level of atrial fibrillation–related disability. The Results have been corrected and now state that a higher Atrial Fibrillation Effect on Quality of Life score indicates a lower level of atrial fibrillation–related disability.

Author Contributions: Drs Mark and Anstrom had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Mark, Anstrom, Monahan, Bahnson, Poole, Rosenberg, Lee, Packer.

Acquisition, analysis, or interpretation of data: Mark, Anstrom, Sheng, Piccini, Baloch, Daniels, Bahnson.

Drafting of the manuscript: Mark, Baloch, Daniels, Packer.

Critical revision of the manuscript for important intellectual content: Anstrom, Sheng, Piccini, Monahan, Daniels, Bahnson, Poole, Rosenberg, Lee, Packer.

Statistical analysis: Mark, Anstrom, Sheng, Lee.

Obtained funding: Mark, Lee, Packer.

Administrative, technical, or material support: Baloch, Monahan, Daniels, Rosenberg, Packer.

Supervision: Baloch, Monahan, Packer.

Conflict of Interest Disclosures: Dr Mark reported receiving grants from the National Institutes of Health (NIH) and Mayo Clinic during the conduct of the study; grants from Merck, Oxygen Therapeutics, Bristol-Myers Squibb, AstraZeneca, the University of Calgary, Eli Lilly & Company, AGA Medical, St Jude Medical, and Tufts University and personal fees from CeleCor and Novo Nordisk outside the submitted work. Dr Anstrom reported receiving grants from NIH during the conduct of the study. Dr Piccini reported receiving grants from ARCA biopharma, personal fees from Allergan, grants and personal fees from Abbott, grants from Boston Scientific, personal fees from Biotronik, grants from Gilead, personal fees from GlaxoSmithKline, grants from Janssen, personal fees from Medtronic, personal fees from Motif Bio, personal fees from Phillips, and personal fees from Sanofi outside the submitted work. Ms Monahan reported receiving grants from NIH, St Jude Foundation and Corporation, Biosense Webster Inc, Medtronic Inc, and Boston Scientific Corporation during the conduct of the study; providing consulting services to Biosense Webster Inc and providing consulting services to and receiving personal fees from Thermedical Inc outside the submitted work. Ms Daniels reported receiving grants from NIH and Mayo Clinic during the conduct of the study and personal fees from CeleCor outside the submitted work. Dr Bahnson reported receiving grants from NIH and Mayo Clinic during the conduct of the study; grants and personal fees and participating as a site primary investigator for a pivotal trial and receiving reimbursement from CardioFocus Inc, grants from Biosense Webster, grants from St Jude Medical, grants from Medtronic, and grants from Boston Scientific outside the submitted work; and a pending patent for a catheter/sheath for intracardiac imaging. Dr Poole reported receiving grants from Mayo Clinic during the conduct of the study and grants from AtriCure outside the submitted work. Dr Lee reported receiving grants from the National Heart, Lung, and Blood Institute (NHLBI) during the conduct of the study. Dr Packer reported receiving grants from NIH/NHLBI, St Jude Medical Corporation and Foundation, Biosense Webster Inc, Medtronic Inc, and Boston Scientific Corp during the conduct of the study; and receiving grants from Abbott, Biosense Webster Inc, Boston Scientific Corp, CardioFocus, Medtronic Inc, St Jude Medical, CardioInsight, NIH, Siemens, Thermedical, Endosense, Robertson Foundation, and Hansen Medical; serving on the advisory board without compensation for Abbott, Biosense Webster Inc, Boston Scientific Corp, CardioFocus, Medtronic Inc, St Jude Medical, Spectrum Dynamics, Siemens, Thermedical, Johnson & Johnson, and SigNum Preemptive Healthcare, Inc; speaking with honorarium from Biotronik and MediaSphere Medical, LLC; receiving royalties from Wiley & Sons, Oxford, and St Jude Medical; Dr Packer and Mayo Clinic jointly have equity in a privately held company, External Beam Ablation Medical Devices, outside the submitted work; Dr Packer has mapping technologies with royalties paid. No other disclosures were reported.

Funding/Support: Supported by grants U01HL89709, U01HL089786, U01HL089907 and U01HL089645 from the National Heart, Lung, and Blood Institute, St Jude Foundation and Corporation, Biosense Webster Inc, Medtronic Inc, Boston Scientific Corporation, and Mayo Clinic.

Role of the Funder/Sponsor: The National Heart, Lung, and Blood Institute was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. St Jude Foundation and Corporation, Biosense Webster Inc, Medtronic Inc, Boston Scientific Corporation, and Mayo Clinic were not involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: The CABANA Investigators.

Executive Committee: Douglas L. Packer, MD, PI, Richard A. Robb, PhD, PI; Kristi H. Monahan, RN, Maryam E. Rettmann, PhD, Mayo Clinic, Rochester, MN; Kerry L. Lee, PhD PI, Daniel B. Mark, MD, MPH, PI, Tristram D. Bahnson, MD, Jonathan P. Piccini, MD, MHS, Beth Martinez, RN, Duke Clinical Research Institute, Duke University, Durham, NC; Jeanne E. Poole, MD, University of Washington Medical Center, Seattle, WA; Alice Mascette, MD, Yves Rosenberg, MD, MPH, Neal Jeffries, PhD, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD; L. Brent Mitchell, MD, Libin Cardiovascular Institute, Alberta Canada; Greg G. Flaker, MD, University of Missouri-Columbia, Columbia, MO.

Statistical and Data Coordinating Center: Kerry L. Lee, PhD, PI, Hussein R. Al-Khalidi, PhD, Tristram D. Bahnson, MD, Adam Silverstein, MS, Alicia Ellis, PhD, Beth Martinez, MS, PMP, Sheri A Ussery, RN, CCRA, Kathleen L. Moretz, RN, PMP, DCRI Clinical Operations Team, Duke Clinical Research Institute, Duke University, Durham, NC; Dr Sarah Hagen, International Clinical Operations Team, World Wide Clinical Trials, Berlin Germany.

Quality of Life Investigational Team: Daniel B. Mark, MD, MPH, PI, Kevin Anstrom, PhD, Khaula Baloch, MPH, Diane M. Liu, CTC, Janet Blount, Shubin Sheng PhD, Melanie R. Daniels, BA, DCRI Outcomes Call Center Staff and Interviewers, Duke Clinical Research Institute, Duke University, Durham, NC.

Economics Investigational Team: Daniel B. Mark, MD, MPH, PI, Patricia Cowper, PhD, Kevin Anstrom, PhD, David Knight, MS, Elizabeth F. O’Neal, BA, Melanie R. Daniels, BA, Duke Clinical Research Institute, Duke University, Durham, NC.

Image Analysis Investigational Lab: Richard A. Robb, PhD, PI, David R Holmes III, PhD, Maryam E. Rettmann, PhD, Jerome Breen, MD, Biomedical Imaging Resource Core, Mayo Clinic, Rochester, MN.

Steering Committee: L. Brent Mitchell, MD, Libin Cardiovascular Institute, Alberta, Canada; Greg G. Flaker, MD, University of Missouri-Columbia, Columbia, MO; David Wilber, MD, Loyola Medicine, Maywood, IL; James Reiffel, MD, Columbia University College of Physicians and Surgeons, New York, NY; Peter Kowey, MD, Lankenau Medical Center, Wynnewood, PA; Gerald Naccarelli, MD, Pennsylvania State Hershey Cardiovascular Institute, Hershey, PA; John P. DiMarco, MD, PhD, University of Virginia Health Sciences Center, Charlottesville, VA; D. Wyn Davies, MD, St Mary's Hospital, London, England UK; Riccardo Cappato MD, Milan, Italy; Jon M. Kalman, MD, PhD, Royal Melbourne Hospital, Parkville, Victoria Australia; Karl-Heinz Kuck, MD, Asklepios Klinik St George, Hamburg, Germany; Gerhardt Hindricks, MD, Herzzentrum Leipzig, Leipzig, Germany; Hugh Calkins, MD, Johns Hopkins University, Baltimore, MD; William G. Stevenson, MD, Brigham and Women’s Hospital, Boston, MA.

Data and Safety Monitoring Board: Alfred Buxton, MD (Chair), Beth Israel Deaconess Medical Center, Boston, MA; Anne B. Curtis, MD, University of Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY; Barry R. Davis, MD, PhD, University of Texas School of Public Health, Houston, TX; Connie M. Ulrich, PhD, RN, FAAN, University of Pennsylvania School of Nursing, Philadelphia, PA; Ralph Lazzara, MD, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Terry Peters, PhD, Robarts Research Institute, London, Ontario Canada.

Clinical Events Committee: L. Brent Mitchell, MD (Chair), University of Calgary, Calgary, Alberta Canada; Jared T. Bunch, MD, Intermountain Medical Center, Murray UT; James Daubert, MD, Duke University, Durham, NC; Blair Halperin, MD, Providence St Vincent Medical Center/Portland, OR; John Holshouser, MD, The Sanger Clinic, PA/Charlotte, NC; Steven Kutalek, MD, Drexel University College of Medicine, Philadelphia, PA; Greg Michaud, MD, Vanderbilt University, Nashville, TN; Paul Mounsey, MD, University of North Carolina, Chapel Hill, NC; George Wyse, MD, Libin CV Institute/U of Calgary, Calgary, Alberta Canada.

Neurological (Stroke) Clinical Events Committee: Greg Flaker (Chair), MD, University of Missouri, Columbia, MO; Rodney Bell, MD, Thomas Jefferson University Hospital, Philadelphia, PA; Arnold Greenspon, MD, Thomas Jefferson University Hospital, Philadelphia, PA; William Logan, MD, Mercy Clinic, St Louis, MO; Pradeep Sahota, MD, Niranjan Singh, MD, University of Missouri-Columbia, Columbia, MO.

CABANA Innovative Ablation Therapy Committee: D. Wyn Davies, MD (Chair), St Mary’s Hospital London, England, United Kingdom; Hugh Calkins, MD, Johns Hopkins Hospital, Baltimore, MD; Richard Schilling, MD, Queen Mary, University of London, England, United Kingdom; Atul Verma, MD, Newmarket Cardiology Research Group, Newmarket, Ontario Canada; Tristram Bahnson, MD, Duke Clinical Research Institute, Durham, NC; Brian DeVille, MD, The Heart Hospital Baylor Plano, Plano, TX; Kristi Monahan, RN, Mayo Clinic, Rochester, MN.

CABANA Innovative Drug Therapy Committee: John DiMarco, MD (Chair) University of Virginia Health Sciences Center, Charlottesville, VA; Gerald Naccarelli, MD, Penn State Hershey Cardiovascular Institute, Hershey, PA; Peter Kowey, MD, Lankenau Medical Center, Wynnewood, PA; James Reiffel, MD, Columbia University College of Physicians and Surgeons, New York, NY; Mario Gonzalez, MD, Milton Hershey Medical Center, Hershey, PA; Kristi Monahan, RN, Mayo Clinic, Rochester, MN.

ECG Adjudication Committee: Jeanne Poole MD, (Chair), Kris Patton, MD, Jordan Prutkin, MD, University of Washington Medical Center, Seattle, WA; George Johnson, Independent Contractor, Seattle, WA; Nazem Akoum, MD, University of Washington, Seattle, WA; Pierre Auokar, MD, Joseph Blatt, MD, Kaiser Permanente, San Diego, CA; Ulrika (Riki) Birgersdotter-Green, MD, University of California, San Diego, CA; Yong-Mei Cha, MD, Siva Mulpuru, MD, Peter Noseworthy, MD, Mayo Clinic, Rochester, MN; Mina Chung, MD, Cleveland Clinic, Cleveland, OH; Marye Gleva, MD, Washington University Medical Center, St Louis, MO; Taya Glotzer, MD, Hackensack University Medical Center, Hackensack, NJ; Charles Henrikson, MD, Eric Stecker, MD, Oregon Health & Science University, Portland, OR; Yousuf Kanjwal, MD, University of Toledo, Toledo, OH; Jack Kron, MD, Oregon Health & Science University, Portland, OR; Vikas Kuriachan, MD, Alberta Health Services, Alberta Canada; Owen Obel, MD, University of Texas Southwestern, Dallas, TX; Ravi Ranjan, MD, University of Utah, Salt Lake City, UT; Robert Rho, MD, Virginia Mason Medical Center, Seattle WA; Andrea Russo, MD, Cooper University Hospital, Camden, NJ; Renee Sullivan, MD, University of Missouri, Columbia, MO; Wendy Tzou, MD, University of Colorado Health, Denver, CO; Sarina van der Zee, MD, Pacific Heart Institute, Santa Monica, CA; Laura Vitali Serdoz, MD, Klinikum Coburg, Coburg, Germany.

CABANA Rhythm Monitoring: Mauri Wilson, RN, BSN, BSES (Clinical Research Liaison), Wayne Bowen, EMT-P, CCT (Clinical Trial Associate), Medicomp Cardiac Monitoring Centers, Melbourne, FL.

Clinical Site Principal Investigators and Institutions: (Listed in descending order of the number of randomized patients) Evgeny Pokushalov, Alexander Romanov, E. Meshalkin, National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation (147); T. Jared Bunch, Intermountain Medical Center/Murray, UT (139); Tristram Bahnson, Duke University Medical Center, Durham, NC (133); Georg Noelker, Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany (98); Douglas Packer, Mayo Clinic, Rochester, MN (93); Gerhard Hindricks, Herzzentrum Leipzig, Leipzig, Germany (88); Andrey Ardashev, Clinical Hospital # 83 under the Federal Medical and Biological Agency, Moscow, Russia (66); Amiran Revishvili, George Matsonashvili, Bakoulev Scientific Center for Cardiovascular Surgery, Moscow, Russia (52); Pugazhendhi Vijayaraman, Geisinger Wyoming Valley Medical Center, Wilkes-Barre, PA (43); Huseyin Ince, Universitat Rostock, Rostock, Germany (previously Dietmar Baensch) (42); Christopher Piorkowski, Technische Universitat Dresden, Dresden, Germany (41); Thomas Neumann, Kerckhoff Klinik, Bad Nauheim, Germany (40); George Veenhuyzen, University of Calgary, Calgary, AB (39); Anil Gehi, University of North Carolina at Chapel Hill, Chapel Hill, NC (previously Paul Mounsey) (38); David Wilber, Loyola University Medical Center, Maywood, IL (36); Felix Sogade, Georgia Arrhythmia Consultants, Macon, GA (34); Carlo Pappone, Policlinico San Donato Center of Clinical Arrhythmia and Electrophysiology, San Donato Milanese, Italy (previously Riccardo Cappato) (32); Adam Berman, Georgia Regents University, Augusta, GA (31); Alaa Shalaby, V.A. Pittsburgh Healthcare System, Pittsburgh, PA (25); Karl-Heinz Kuck, Asklepios Klinik St George, Hamburg, Germany (25); Blair Halperin, Providence St Vincent Medical Center, Portland, OR (25); Venkat Tholakanahalli, Minneapolis V.A. Medical Center, Minneapolis, MN (24); Eugen Palma, Montefiore Medical Center, New York, NY (24); John Holshouser, The Sanger Clinic, PA, Charlotte, NC (24); Nitish Badhwar, University of California at San Francisco Medical Center, San Francisco, CA (23); Haroon Rashid, Virginia Hospital Center - Arlington, VA (23); Craig Cameron, Oklahoma Heart Institute, Tulsa, OK (22); John Hummel, The Ohio State University Medical Center, Columbus, OH (22); Pablo Saavedra, Vanderbilt University Medical Center, Nashville, TN (previously Dawood Darbar) (21); J. Brian Deville, The Heart Hospital Baylor Plano, Plano, TX (21); Julian Chun, CCB - Cardioaniologisches Centrum Bethanien, Frankfurt, Germany (20); Javier Roman-Gonzalez, South Texas Cardiovascular Consultants, San Antonio, TX (20); Stephen Willems, Universitares Herzzentrum Hamburg, Hamburg, Germany (20); Hasan Garan, Columbia University Medical Center, New York, NY (20); Eric Michael Crespo, Hartford Hospital, Hartford, CT (19); Peter Cheung, Scott and White Memorial Hospital, Temple, TX (previously David Fitzgerald) (18); Gerian Groenefeld, Asklepios Klinik Barmbek, Hamburg, Germany (17); Claudio Schuger, Henry Ford Hospital, Detroit, MI (16); Tariq Salam, Cardiac Study Center, Tacoma, WA (16); Yanzong Yang, The First Affiliated Hospital of Dalian Medical University, Dalian, China (15); Carlo Pappone, Maria Cecilia Hospital, Cotignola, Italy (15); Dan Wichterle, Charles University, Prague 2, Czech Republic (15); Johannes Brachmann, Klinikum Coburg, Coburg, Germany (15); Josef Kautzner, Clinic of Cardiology IKEM Medical Institute, Prague 4, Czech Republic (15); John Jayachandran, Baylor All Saints Medical Center, Ft Worth, TX (15); Young-Hoon Kim, Korea University Anam Hospital, Seoul, Korea (14); Christopher Cole, Penrose St Francis Health Services, Colorado Springs, CO (14); Bengt Herweg, University of South Florida, Tampa, FL (13); Martin Lowe, The Heart Hospital, London, United Kingdom (12); Anne Dougherty, University of Texas Health Science Center at Houston, Houston, TX (previously Bharat Kantharia, Nada Memon) (12); Sergey Popov, Scientific Research Institute of Cardiology of Siberian Dept of Russian Academy of Medical Sciences, Tomsk, Russia (11); Martin Lowe, St Bartholomew's Hospital, London, United Kingdom (previously Richard Schilling) (11); Stefan Spitzer, Praxisklinik Herz and GefaBe, Dresden, Germany (11); Robert Bernstein, Sentara Norfolk General Hospital, Norfolk, VA (11); Jay Simonson, Park Nicollet Heart and Vascular Center/Methodist Hospital, St Louis Park, MN (11); Eric Buch, University of California Los Angeles, Los Angeles, CA (10); Shulin Wu, Guangdong Provincial People's Hospital, Guangzhou, China (10); Mohammed Khan, Alexian Brothers Medical Center, Elk Grove Village, IL (10); Timothy Shinn, St Joseph Mercy Hospital, Ann Arbor, MI (previously James Kappler) (10); Petr Neuzil, Na Homolce Hospital, Prague, Czech Republic (9); James Mangrum, University of Virginia Health System, Charlottesville, VA (9); Hugh Calkins, Johns Hopkins Hospital, Baltimore, MD (9); Mario Gonzalez, Penn State University Cardiovascular Center, Hershey, PA (9); Moussa Mansour, Massachusetts General Hospital, Boston, MA (9); Markus Zabel, Georg-August-University, Goettingen, Germany (8); Jonathan Kalman, Royal Melbourne Hospital, Parkville, Australia (8); Jose Sanchez, St John's Mercy Heart Hospital, St Louis, MO (8); Steven Rothman, Lankenau Medical Center, Wynnewood, PA (8); Anil Bhandari, Good Samaritan Hospital, Los Angeles, CA (8); Cynthia Tracy, George Washington University Medical Center, Washington, DC (8); Raul Mitrani, University of Miami Health System, Miami, FL (7); Vicken Vorperian, Waukesha Memorial Hospital, Waukesha, WI (7); Derek Connelly, Golden Jubilee Hospital, Glasgow, United Kingdom (7); Darryl Wells, Swedish Medical Center - Providence Campus, Seattle, WA (7); Chang-Sheng Ma, Beijing Anzhen Hospital, Beijing, China (7); Atul Verma, Southlake Regional Health Centre, Newmarket, ON (7); S. Luke Kusmirek, Drexel University College of Medicine, Philadelphia, PA (7); Melissa Robinson, University of Washington Medical Center, Seattle, WA (previously Robert Rho, Mohan Viswanathan) (7); Donald Rubenstein, Greenville Hospital System University Medical Center, Greenville, SC (6); Emilio Vanoli, Policlinico Multimedical Cardiology and Arrhythmia Centre, Milan, Italy (previously Annibale Montenero) (6); Shu Zhang, Fuwai Hospital, Beijing, China (6); Jennifer Cummings, The University of Toledo, Toledo, OH (previously Mohammed Kanjwal) (6); Mohan Viswanathan, Stanford University Medical Center, Stanford, CA (previously Amin Al Ahmad, Paul Zei) (6); George Monir, Florida Hospital, Orlando, FL (6); Francis Marchlinski, University of Pennsylvania Health System, Philadelphia, PA (6); Jay Franklin, Baylor Heart and Vascular Hospital, Dallas, TX (previously Robert Kowal) (6); Bruce Koplan, Brigham and Women's Hospital, Boston, MA (previously Gregory Michaud) (6); Prashanthan Sanders, Royal Adelaide Hospital, Adelaide, Australia (5); Eric Rashba, Stony Brook University Medical Center, Stony Brook, NY (5); Mark Gallagher, St George's Hospital Medical School, London, United Kingdom (5); Bernd Gonska, St Vincentius-Kliniken, Karlsruhe, Germany (5); Minglong Chen, First Affiliated Hospital of Nanjing Medical University, Nanjing, China (5); Peter Leong-Sit, University of Western Ontario - London Health Sciences Centre, London, Ontario (5); John Zimmerman, Hackensack University Medical Center, Hackensack, NJ (5); Nayer Pezeshkian, University of California Davis Medical Center, Sacramento, CA (5); Andrew Cohen, The Medical Center of Aurora, Aurora, CO (5); Saulius Kalvaitis, St Louis Heart and Vascular, St Louis, MO (4); David Davies, St Mary's Hospital, London, United Kingdom (4); Martin Borggrefe, University Hospital of Mannheim, Mannheim, Germany (4); Hui-Nam Pak, Yonsei University Severance Hospital, Seoul, Korea (4); Andrea Russo, Cooper University Hospital, Camden, NJ (4); Charles Henrikson, Oregon Health and Science University, Portland, OR (previously Jack Kron) (4); Gerald Greer, Arkansas Cardiology, PA, Little Rock, AR (4); James Coromilas, Robert Wood Johnson University Hospital, New Brunswick, NJ (3); Farhat Khairallah, Tallahassee Memorial Hospital, Tallahassee, FL (3); Guillermo Sosa-Suarez, Albany Associates in Cardiology, Albany, NY (3); Bruce Lindsay, Cleveland Clinic Foundation, Cleveland, OH (3); Westby Fisher, North Shore University Health System, Evanston Hospital, Evanston, IL (3); Steven Bailin, Mercy Medical Center, Des Moines, IA (3); Andy Tran, Scottsdale Healthcare, Scottsdale, AZ (2); Zdenek Starek, St Anne's University Hospital, ICRC, Brno, Czech Republic (2); Mark Preminger, The Valley Hospital, Ridgewood, NJ (2); Robert Sheppard, Northside Hospital and Heart Institute, St Petersburg, FL (2); Alexandru Costea, University of Cincinnati Medical Center, Cincinnati, OH (2); Kenneth Ellenbogen, Virginia Commonwealth University Medical Center, Richmond, VA (2); Thomas Arentz, Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany (1); Roberto De Ponti, Ospedale di Circolo e Fondazione Macchi, Varese, Italy (1); Ryan Aleong, University of Colorado Hospital, Aurora, CO (1); Byron Colley III, Jackson Heart Clinic, Jackson, MS (1); Khawaja Baig, Medisync, Cincinnati, OH (1); Kousik Krishnan, Rush University Medical Center, Chicago, IL (1); Syamkumar Divakara Menon, Hamilton Health Sciences, Hamilton, ON (previously Carlos Morillo) (1); Tony Simmons, Wake Forest University Health Sciences, Winston Salem, NC (1); Gregory Bruce, Memorial Health Care System, Chattanooga, TN (1); Larry Chinitz, Tisch Hospital (New York University Langone Medical Center), New York, NY (1); Andrea Natale, Texas Cardiac Arrhythmia, Austin, TX (1); Riccardo Cappato, IRCCS Istituto Clinico Humanitas, Milano, Italy.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute, the National Institutes of Health, or the US Department of Health and Human Services.

Meeting Presentation: This study was presented at the Late Breaking Trials session of the European Society of Cardiology Congress; August 26, 2018; Munich, Germany.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We are particularly indebted to the coordinators at the CABANA sites who collected study data and to the patients who agreed to provide their quality of life data for the trial.

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