Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)

The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmia
• Intervention / Treatment: Device: Left atrial ablation; Drug: Rate or Rhythm Control Therapy

Detailed Description

The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.

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.

• Study Type: Interventional
• Enrollment (Actual): 2204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences
    • London, Ontario, Canada, N6A 5A5
      • University of Western Ontario - London Health Sciences Centre
    • Newmarket, Ontario, Canada, L3Y 8C3
      • Southlake Regional Health Centre
• China
  • Beijing, China, 100029
    • Beijing Anzhen Hospital
  • Beijing, China, 100037
    • Fuwai Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • First Affiliated Hospital of Nanjing Medical University
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • First Affiliated Hospital of Dalian Medical University
• Czechia
  • Brno, Czechia, 65691
    • Saint Anne's University Hospital, ICRC
  • Prague 2, Czechia, 12808
    • Charles University
  • Prague 4, Czechia, 14021
    • Clinic of Cardiology IKEM Medical Institute
  • Hlavni Mesto Praha
    • Prague 5, Hlavni Mesto Praha, Czechia, 150 30
      • Na Homolce Hospital
• Germany
  • Bad Nauheim, Germany, D-61231
    • Kerckhoff Klinik
  • Dresden, Germany, 01324
    • Praxisklinik Herz and GefaBe
  • Frankfurt, Germany, 60431
    • CCB - Cardioaniologisches Centrum Bethanien
  • Gottingen, Germany, 37075
    • Georg-August-University
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamburg, Germany, 22291
    • Asklepios Klinik Barmbek
  • Karlsruhe, Germany, 76137
    • Saint Vincentius-Kliniken
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig
  • Rostock, Germany, D-18057
    • Universität Rostock
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • University hospital of Mannheim
  • Bayern
    • Coburg, Bayern, Germany, 96450
      • Klinikum Coburg
  • Freie-Hansestadt Hamburg
    • Hamburg, Freie-Hansestadt Hamburg, Germany, 20246
      • Universitares Herrzentrum Hamburg
  • Nordrhein-Westfalen
    • Bad Oeynhausen, Nordrhein-Westfalen, Germany, D-32545
      • Herz-und Diabeteszentrum NRW
  • Saxony
    • Dresden, Saxony, Germany, D-01307
      • Technische Universität Dresden
• Italy
  • Milan, Italy, 20099
    • Policlinico Multimedical Cardiology and Arrhythmia Centre
  • Varese, Italy, 21100
    • Ospedale di Circolo e Fondazione Macchi
  • Lombardia
    • San Donato Milanese, Lombardia, Italy, 20097
      • Policlinico San Donato Center of Clinical Arrhythmia and Electrophysiology
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
• Russian Federation
  • Moscow, Russian Federation, 115682
    • Clinical Hospital # 83 under the Federal Medical and Biological Agency
  • Moscow, Russian Federation, 121552
    • Bakoulev Scientific Center for Cardiovascular Surgery
  • Tomsk, Russian Federation, 634012
    • Scientific Research Institute of Cardiology of Ministry of Health of Russian Foundation
  • Novosibirskaya Oblast
    • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630055
      • Research Institute of Circulation of Pathology
• United Kingdom
  • Glasgow, United Kingdom, G81 4HX
    • Golden Jubilee Hospital
  • London, United Kingdom, EC1A 7BE
    • Saint Bartholomew's Hospital
  • London, United Kingdom, SW17 0QT
    • Saint George's Hospital Medical School
  • London, United Kingdom, W2 1NY
    • Saint Mary's Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cardiology, PA
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Francisco, California, United States, 94143
      • University of California at San Francisco Medical Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80012
      • The Medical Center of Aurora
    • Colorado Springs, Colorado, United States, 80907
      • Penrose Saint Francis Health Services
  • Connecticut
    • Hartford, Connecticut, United States, 06115
      • Hartford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Faculty Associates
  • Florida
    • Miami, Florida, United States, 60612
      • University of Miami Hospital
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital and Heart Institute
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
    • Tampa, Florida, United States, 33606
      • Florida Heart Rhythm-University of South Florida College of Medicine
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
    • Macon, Georgia, United States, 31201
      • Georgia Arrhythmia Consultants & Research Institute
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Alexian Brothers Medical Center
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Iowa
    • West Des Moines, Iowa, United States, 50226
      • Mercy Medical Center-Iowa Heart Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Ypsilanti, Michigan, United States, 48197
      • Saint Joseph Mercy Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis V.A. Medical Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
    • Saint Louis Park, Minnesota, United States, 55426
      • Park Nicollet Methodist Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Saint John's Mercy Heart Health Center
    • Saint Louis, Missouri, United States, 63136
      • Saint Louis Heart and Vascular
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson University Hospital
  • New York
    • Albany, New York, United States, 12205
      • Albany Associates In Cardiology
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • Stony Brook, New York, United States, 11794-8167
      • Stony Brook University Hospital and Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28203
      • The Sanger Clinic, PA
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44193
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Saint Vincent Medical Center
    • Portland, Oregon, United States, 97201
      • Oregon Health and Science University
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2160
      • Geisinger Wyoming Valley Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University Cardiovascular Center
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
    • Pittsburgh, Pennsylvania, United States, 15240
      • V.A. Pittsburgh Healthcare System
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System University Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Memorial Health Care System
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Fort Worth, Texas, United States, 76104
      • Baylor All Saints Medical Center
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78299
      • South Texas Cardiovascular Consultants
    • Temple, Texas, United States, 76508
      • Scott and White Memorial Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • Intermountain Medical Center-LDS Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Falls Church, Virginia, United States, 22042
      • Virginia Hospital Center - Arlington
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center - Providence Campus
    • Tacoma, Washington, United States, 98405
      • Cardiac Study Center
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Over the preceding 6 months have:

  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:

• Lone AF in the absence of risk factors for stroke in patients <65 years of age
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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
Active Comparator: 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.	All events for each component of the primary endpoint were reviewed and adjudicated in a blinded fashion by an independent clinical events committee using prospectively determined event definitions. Death was defined as all-cause mortality, disabling stroke (including intracranial bleeding) as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2, and serious bleeding as bleeding accompanied by hemodynamic compromise that required surgical intervention or a transfusion of ≥3 units of blood.	From date of enrollment until time-to-first event over a median follow-up of 48.5 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With All-cause Mortality	All deaths were reviewed and adjudicated by the Clinical Events Committee	From date of enrollment until date of death over a median follow-up of 48.5 months.
Number of Participants With Mortality or Cardiovascular (CV) Hospitalization	Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.	From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months.
Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events)	Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2 and the reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.	From date of enrollment until time-to-first event of death, stroke, or CV hospitalization (for heart failure or acute ischemic event) over a median follow-up of 48.5 months.
Number of Participants With Cardiovascular Death	Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator	From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months.
Number of Participants With Cardiovascular Death or Disabling Stroke	Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2.	From date of enrollment until time-to-first event of a cardiovascular death or disabling stroke over a median follow-up of 48.5 months.
Number of Participants With an Arrhythmic Death or Cardiac Arrest	All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee	From date of enrollment until time-to-first event for an arrhythmic death or cardiac arrest over a median follow-up of 48.5 months.
Number of Participants With Heart Failure Death	All deaths were categorized and adjudicated by the Clinical Events Committee	From date of enrollment until date of heart failure death over a median follow-up of 48.5 months.
Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period	Data from patients using the study provided ECG event recording system were analyzed. A 30-second episode of AF in either group, confirmed through blinded review by an ECG Core Lab Committee was used for defining the endpoint of recurrent AF.	From date of therapy initiation until date of first AF recurrence following a 90 day wait (blanking) period over a median follow-up of 48.5 months.
Number of Participants With Cardiovascular Hospitalization	The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.	From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months.
Changes in Quality of Life Measures - AFEQT	Atrial Fibrillation Effect on Quality of Life (AFEQT) Overall Score (Scale: 0 = complete disability, 100 = no disability). The AFEQT is a 21-item AF-specific, health-related QOL questionnaire designed to assess the effect of atrial fibrillation on patient quality of life. The AFEQT has an Overall Score (calculated from 18 of the questions) and subscale scores in three domains: symptoms, daily activities, and treatment concern. Overall and subscale scores range from 0 (corresponds to complete disability) to 100 (no AF-related disability).	Baseline ,12 month, 5 years
Changes in Quality of Life Measures - MAFSI Frequency Score	The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI frequency of symptoms over the past month was recorded as 0 (never), 1 (rarely), 2 (sometimes), 3 (often), and 4 (always) for each of the 10 items listed in the questionnaire. The 10 item responses were summed for a total Frequency Score that ranged from 0 (no AF symptoms) to 40 (worst score).	Baseline, 12 Month, 5 Year
Changes in Quality of Life Measures - MAFSI Severity Score	The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI severity scores over the past month were recorded as 1 (mild), 2 (moderate), and 3 (extreme) for each of the 10 items listed in the questionnaire. The 10 items items were then summed for the total Severity Score that ranged from 0 (no AF symptoms) to 30 (most severe AF symptoms).	Baseline, 12 Month, 5 Year
Number of Participants With Adverse Events/Complications	Comparing individual non-endpoint adverse events between ablative and drug therapy is difficult due to the substantial difference in the types of adverse events expected. Ablation-related events were counted among all patients that were randomized to and received an ablation. Drug-related events were counted among all patients that were randomized to and received drug therapy.	From treatment start date to date of event over a median follow-up of 48.5 months.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Abbott Medical Devices; Biosense Webster, Inc.
• Investigators: Principal Investigator: Douglas L. Packer, M.D., Mayo Clinic; Principal Investigator: Kerry L. Lee, Ph.D., Duke Clinical Research Institute; Principal Investigator: Daniel B. Mark, M.D., MPH, Duke Clinical Research Institute; Principal Investigator: Rich A. Robb, Ph.D. Phy, Mayo Clinic; Study Chair: Yves D. Rosenberg, M.D., MPH, National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

General Publications

• 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. Erratum In: JAMA. 2019 Jun 18;321(23):2370.
• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2009
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 29, 2009
• First Posted (Estimate): June 2, 2009

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Catheter Ablation; Left Atrial Ablation; Pulmonary Vein Isolation; Antiarrhythmic Drug Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 09-004616; U01HL089709 (U.S. NIH Grant/Contract)