Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
NCT ID: NCT00911508
Last Updated: 2021-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2204 participants
INTERVENTIONAL
2009-11-13
2017-12-31
Brief Summary
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Detailed Description
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This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or \<65 with \>1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment.
The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Left Atrial Ablation
Pulmonary vein isolation using a circumferential ablative approach in the left atrium. Ablation may be performed using circular mapping catheter-guided ablation, antral isolation using a circular guided approach, or wide area circumferential ablation.
Left atrial ablation
St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path
Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF
Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System
Bard: Stinger
Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath
Rate or Rhythm Control Therapy
Current state-of-the-art drug therapy for atrial fibrillation (rate control or rhythm control). Treating physicians will be encouraged to follow the American College of Cardiology / American Heart Association / European Society of Cardiology Atrial Fibrillation Guidelines with regard to drug therapy for atrial fibrillation. The specific choice of rate control versus rhythm control drug therapy and the specific drugs to be used will ultimately be left to the discretion of the treating physician.
Rate or Rhythm Control Therapy
Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg
Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg, Dronedarone 800mg
Interventions
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Left atrial ablation
St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path
Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF
Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System
Bard: Stinger
Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath
Rate or Rhythm Control Therapy
Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg
Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg, Dronedarone 800mg
Eligibility Criteria
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Inclusion Criteria
1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) atrial fibrillation (AF) episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
2. electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
3. electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration \>1 year).
* Warrant active therapy (within the past 3 months) beyond simple ongoing observation
* Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs.
* Be ≥65 yrs of age, or \<65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a blood pressure \>140/90 mmHg) \[90\], Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) \[91\], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, transient ischemic attack or systemic emboli, Atherosclerotic vascular disease (previous myocardial infarction (MI), peripheral arterial disease or aortic plaque), left atrial (LA) size \>5.0 cm (or volume index ≥40 cc/m2), or ejection fraction (EF) ≤35.
* Have the capacity to understand and sign an informed consent form.
* Be ≥18 years of age.
* NOTE- Subjects \<65 yrs of age whose only risk factor is hypertension must have a second risk factor or left ventricular (LV) hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment.
Exclusion Criteria
* Patients who in the opinion of the managing clinician should not yet receive any therapy for AF
* Patients who have failed \>2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects (Table 5.2.2)
* An efficacy failure of full dose amiodarone treatment \>8 weeks duration at any time
* Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
* Recent cardiac events including MI, percutaneous intervention (PCI), or valve or bypass surgery in the preceding 3 months
* Hypertrophic obstructive cardiomyopathy (outflow track)
* Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation)
* Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. ventricular tachycardia (VT), ventricular fibrillation (VF))
* Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
* Prior LA catheter ablation with the intention of treating AF
* Prior surgical interventions for AF such as the MAZE procedure
* Prior AV nodal ablation
* Patients with other arrhythmias requiring ablative therapy
* Contraindication to appropriate anti-coagulation therapy
* Renal failure requiring dialysis
* Medical conditions limiting expected survival to \<1 year
* Women of childbearing potential (unless post-menopausal or surgically sterile)
* Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center)
* Unable to give informed consent
* NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is not an exclusion.
18 Years
90 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Abbott Medical Devices
INDUSTRY
Biosense Webster, Inc.
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Douglas L. Packer, MD
MD
Principal Investigators
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Douglas L. Packer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Kerry L. Lee, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Daniel B. Mark, M.D., MPH
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Rich A. Robb, Ph.D. Phy
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Yves D. Rosenberg, M.D., MPH
Role: STUDY_CHAIR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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Arkansas Cardiology, PA
Little Rock, Arkansas, United States
Good Samaritan Hospital
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California at San Francisco Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Penrose Saint Francis Health Services
Colorado Springs, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
University of Miami Hospital
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
Northside Hospital and Heart Institute
St. Petersburg, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Florida Heart Rhythm-University of South Florida College of Medicine
Tampa, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Georgia Arrhythmia Consultants & Research Institute
Macon, Georgia, United States
Alexian Brothers Medical Center
Barrington, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Mercy Medical Center-Iowa Heart Center
West Des Moines, Iowa, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Joseph Mercy Hospital
Ypsilanti, Michigan, United States
Minneapolis V.A. Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Park Nicollet Methodist Hospital
Saint Louis Park, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Saint John's Mercy Heart Health Center
St Louis, Missouri, United States
Saint Louis Heart and Vascular
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Albany Associates in Cardiology
Albany, New York, United States
New York University Langone Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Stony Brook University Hospital and Medical Center
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Sanger Clinic, PA
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Geisinger Wyoming Valley Medical Center
Danville, Pennsylvania, United States
Penn State University Cardiovascular Center
Hershey, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
V.A. Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States
Memorial Health Care System
Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Baylor All Saints Medical Center
Fort Worth, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Intermountain Medical Center-LDS Hospital
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Hospital Center - Arlington
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Swedish Medical Center - Providence Campus
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Cardiac Study Center
Tacoma, Washington, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
University of Calgary
Calgary, Alberta, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
University of Western Ontario - London Health Sciences Centre
London, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Beijing Anzhen Hospital
Beijing, , China
Fuwai Hospital
Beijing, , China
Na Homolce Hospital
Prague, Prague, Czechia
Saint Anne's University Hospital, ICRC
Brno, , Czechia
Charles University
Prague, , Czechia
Clinic of Cardiology IKEM Medical Institute
Prague, , Czechia
University Hospital of Mannheim
Mannheim, Baden-Wurttemberg, Germany
Klinikum Coburg
Coburg, Bavaria, Germany
Universitares Herrzentrum Hamburg
Hamburg, City state of Hamburg, Germany
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany
Technische Universitat Dresden
Dresden, Saxony, Germany
Kerckhoff Klinik
Bad Nauheim, , Germany
Praxisklinik Herz and GefaBe
Dresden, , Germany
CCB - Cardioaniologisches Centrum Bethanien
Frankfurt, , Germany
Georg-August-University
Göttingen, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Asklepios Klinik Barmbek
Hamburg, , Germany
Saint Vincentius-Kliniken
Karlsruhe, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Universitat Rostock
Rostock, , Germany
Policlinico San Donato Center of Clinical Arrhythmia and Electrophysiology
San Donato Milanese, Lombardy, Italy
Policlinico Multimedical Cardiology and Arrhythmia Centre
Milan, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Research Institute of Circulation of Pathology
Novosibirsk, Novosibirsk Oblast, Russia
Clinical Hospital # 83 under the Federal Medical and Biological Agency
Moscow, , Russia
Bakoulev Scientific Center for Cardiovascular Surgery
Moscow, , Russia
Scientific Research Institute of Cardiology of Ministry of Health of Russian Foundation
Tomsk, , Russia
Korea University Anam Hospital
Seoul, , South Korea
Yonsei University Severance Hospital
Seoul, , South Korea
Golden Jubilee Hospital
Glasgow, , United Kingdom
Saint Bartholomew's Hospital
London, , United Kingdom
Saint George's Hospital Medical School
London, , United Kingdom
Saint Mary's Hospital
London, , United Kingdom
Countries
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References
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Wang Z, Wu Y, Jiang C, He L, Zhou N, Sang C, Dong J, Ma C. Catheter Ablation vs Drug Therapy in Patients With Atrial Fibrillation and Nonmodifiable Recurrence Risk Factors: A Secondary Analysis of the CABANA Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2528124. doi: 10.1001/jamanetworkopen.2025.28124.
Zhang J, Wang L, Li Y, Li Q, Liu X, Weng S, Yin Y, Liang Z, Zhang T, Wang Y. Atrial fibrillation phenotypes identified through cluster analysis in the CABANA study. Int J Cardiol. 2025 Nov 1;438:133606. doi: 10.1016/j.ijcard.2025.133606. Epub 2025 Jul 9.
Martens P, Augusto SN Jr, Erzeel J, Pison L, Mullens W, Tang WHW. Effects of Atrial Fibrillation Ablation for Heart Failure With Preserved Ejection Fraction: Insights From CABANA. JACC Heart Fail. 2025 May;13(5):785-794. doi: 10.1016/j.jchf.2025.01.029. Epub 2025 Apr 16.
Bunch TJ, Poole JE, Silverstein AP, Lee KL, Al-Khalidi HR, Hindricks G, Romanov A, Pokushalov E, Bahnson TD, Daniels MR, Piccini JP, Mark DB, Packer DL; CABANA Investigators. Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial. Circ Arrhythm Electrophysiol. 2024 May;17(5):e012697. doi: 10.1161/CIRCEP.123.012697. Epub 2024 Apr 17.
Cappato R, Mark DB, Silverstein AP, Noseworthy PA, Bonitta G, Poole JE, Piccini JP, Bahnson TD, Daniels MR, Al-Khalidi HR, Lee KL, Packer DL; CABANA Investigators. Regional differences in outcomes with ablation versus drug therapy for atrial fibrillation: Results from the CABANA trial. Am Heart J. 2024 Apr;270:103-116. doi: 10.1016/j.ahj.2024.01.009. Epub 2024 Feb 1.
Zeitler EP, Li Y, Silverstein AP, Russo AM, Poole JE, Daniels MR, Al-Khalidi HR, Lee KL, Bahnson TD, Anstrom KJ, Packer DL, Mark DB; CABANA Investigators. Effects of Ablation Versus Drug Therapy on Quality of Life by Sex in Atrial Fibrillation: Results From the CABANA Trial. J Am Heart Assoc. 2023 Feb 7;12(3):e027871. doi: 10.1161/JAHA.122.027871. Epub 2023 Jan 23.
Monahan KH, Bunch TJ, Mark DB, Poole JE, Bahnson TD, Al-Khalidi HR, Silverstein AP, Daniels MR, Lee KL, Packer DL; CABANA Investigators. Influence of atrial fibrillation type on outcomes of ablation vs. drug therapy: results from CABANA. Europace. 2022 Oct 13;24(9):1430-1440. doi: 10.1093/europace/euac055.
Bahnson TD, Giczewska A, Mark DB, Russo AM, Monahan KH, Al-Khalidi HR, Silverstein AP, Poole JE, Lee KL, Packer DL; CABANA Investigators. Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial. Circulation. 2022 Mar 15;145(11):796-804. doi: 10.1161/CIRCULATIONAHA.121.055297. Epub 2021 Dec 22.
Thomas KL, Al-Khalidi HR, Silverstein AP, Monahan KH, Bahnson TD, Poole JE, Mark DB, Packer DL; CABANA Investigators. Ablation Versus Drug Therapy for Atrial Fibrillation in Racial and Ethnic Minorities. J Am Coll Cardiol. 2021 Jul 13;78(2):126-138. doi: 10.1016/j.jacc.2021.04.092.
Rettmann ME, Holmes DR 3rd, Monahan KH, Breen JF, Bahnson TD, Mark DB, Poole JE, Ellis AM, Silverstein AP, Al-Khalidi HR, Lee KL, Robb RA, Packer DL; CABANA Imaging Investigators. Treatment-Related Changes in Left Atrial Structure in Atrial Fibrillation: Findings From the CABANA Imaging Substudy. Circ Arrhythm Electrophysiol. 2021 May;14(5):e008540. doi: 10.1161/CIRCEP.120.008540. Epub 2021 Apr 13.
Packer DL, Piccini JP, Monahan KH, Al-Khalidi HR, Silverstein AP, Noseworthy PA, Poole JE, Bahnson TD, Lee KL, Mark DB; CABANA Investigators. Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial. Circulation. 2021 Apr 6;143(14):1377-1390. doi: 10.1161/CIRCULATIONAHA.120.050991. Epub 2021 Feb 8.
Russo AM, Zeitler EP, Giczewska A, Silverstein AP, Al-Khalidi HR, Cha YM, Monahan KH, Bahnson TD, Mark DB, Packer DL, Poole JE; CABANA Investigators. Association Between Sex and Treatment Outcomes of Atrial Fibrillation Ablation Versus Drug Therapy: Results From the CABANA Trial. Circulation. 2021 Feb 16;143(7):661-672. doi: 10.1161/CIRCULATIONAHA.120.051558. Epub 2021 Jan 27.
Poole JE, Bahnson TD, Monahan KH, Johnson G, Rostami H, Silverstein AP, Al-Khalidi HR, Rosenberg Y, Mark DB, Lee KL, Packer DL; CABANA Investigators and ECG Rhythm Core Lab. Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the CABANA Trial. J Am Coll Cardiol. 2020 Jun 30;75(25):3105-3118. doi: 10.1016/j.jacc.2020.04.065.
Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.
Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, Daniels MR, Bahnson TD, Poole JE, Rosenberg Y, Lee KL, Packer DL; CABANA Investigators. Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1275-1285. doi: 10.1001/jama.2019.0692.
Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Moretz K, Poole JE, Mascette A, Rosenberg Y, Jeffries N, Al-Khalidi HR, Lee KL; CABANA Investigators. Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: Study Rationale and Design. Am Heart J. 2018 May;199:192-199. doi: 10.1016/j.ahj.2018.02.015. Epub 2018 Mar 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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09-004616
Identifier Type: -
Identifier Source: org_study_id
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