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

• ClinicalTrials.gov Identifier: NCT00911508
• Recruitment Status: Completed
• First Posted: June 2, 2009
• Results First Posted: August 26, 2019
• Last Update Posted: April 21, 2021
• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Abbott Medical Devices; Biosense Webster, Inc.
• Information provided by (Responsible Party): Douglas L. Packer, MD, Mayo Clinic

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Arrhythmia	Device: Left atrial ablation; Drug: Rate or Rhythm Control Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
• Actual Study Start Date: November 13, 2009
• Actual Primary Completion Date: December 31, 2017
• Actual Study Completion Date: December 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. [ Time Frame: From date of enrollment until time-to-first event over a median follow-up of 48.5 months. ]
   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.

Secondary Outcome Measures :

1. Number of Participants With All-cause Mortality [ Time Frame: From date of enrollment until date of death over a median follow-up of 48.5 months. ]
   All deaths were reviewed and adjudicated by the Clinical Events Committee
2. Number of Participants With Mortality or Cardiovascular (CV) Hospitalization [ Time Frame: From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months. ]
   Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.
3. Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events) [ Time Frame: 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. ]
   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.
4. Number of Participants With Cardiovascular Death [ Time Frame: From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months. ]
   Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator
5. Number of Participants With Cardiovascular Death or Disabling Stroke [ Time Frame: 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. ]
   Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2.
6. Number of Participants With an Arrhythmic Death or Cardiac Arrest [ Time Frame: 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. ]
   All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee
7. Number of Participants With Heart Failure Death [ Time Frame: From date of enrollment until date of heart failure death over a median follow-up of 48.5 months. ]
   All deaths were categorized and adjudicated by the Clinical Events Committee
8. Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period [ Time Frame: 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. ]
   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.
9. Number of Participants With Cardiovascular Hospitalization [ Time Frame: From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months. ]
   The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.
10. Changes in Quality of Life Measures - AFEQT [ Time Frame: Baseline ,12 month, 5 years ]
    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).
11. Changes in Quality of Life Measures - MAFSI Frequency Score [ Time Frame: Baseline, 12 Month, 5 Year ]
    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).
12. Changes in Quality of Life Measures - MAFSI Severity Score [ Time Frame: Baseline, 12 Month, 5 Year ]
    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).
13. Number of Participants With Adverse Events/Complications [ Time Frame: From treatment start date to date of event over a median follow-up of 48.5 months. ]

    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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Arkansas

Arkansas Cardiology, PA

Little Rock, Arkansas, United States, 72205

United States, California

Good Samaritan Hospital

Los Angeles, California, United States, 90017

University of California Los Angeles

Los Angeles, California, United States, 90095

University of California Davis Medical Center

Sacramento, California, United States, 95817

University of California at San Francisco Medical Center

San Francisco, California, United States, 94143

Stanford University Medical Center

Stanford, California, United States, 94305

United States, Colorado

The Medical Center of Aurora

Aurora, Colorado, United States, 80012

Penrose Saint Francis Health Services

Colorado Springs, Colorado, United States, 80907

United States, Connecticut

Hartford Hospital

Hartford, Connecticut, United States, 06115

United States, District of Columbia

George Washington University Medical Faculty Associates

Washington, District of Columbia, United States, 20037

United States, Florida

University of Miami Hospital

Miami, Florida, United States, 60612

Florida Hospital

Orlando, Florida, United States, 32803

Northside Hospital and Heart Institute

Saint Petersburg, Florida, United States, 33709

Tallahassee Memorial Hospital

Tallahassee, Florida, United States, 32308

Florida Heart Rhythm-University of South Florida College of Medicine

Tampa, Florida, United States, 33606

United States, Georgia

Georgia Regents University

Augusta, Georgia, United States, 30912

Georgia Arrhythmia Consultants & Research Institute

Macon, Georgia, United States, 31201

United States, Illinois

Alexian Brothers Medical Center

Barrington, Illinois, United States, 60010

Rush University Medical Center

Chicago, Illinois, United States, 60612

NorthShore University Health System

Evanston, Illinois, United States, 60201

Loyola University Medical Center

Maywood, Illinois, United States, 60153

United States, Iowa

Mercy Medical Center-Iowa Heart Center

West Des Moines, Iowa, United States, 50226

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Brigham and Womens Hospital

Boston, Massachusetts, United States, 02115

United States, Michigan

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Saint Joseph Mercy Hospital

Ypsilanti, Michigan, United States, 48197

United States, Minnesota

Minneapolis V.A. Medical Center

Minneapolis, Minnesota, United States, 55417

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Park Nicollet Methodist Hospital

Saint Louis Park, Minnesota, United States, 55426

United States, Mississippi

Jackson Heart Clinic

Jackson, Mississippi, United States, 39216

United States, Missouri

Saint John's Mercy Heart Health Center

Saint Louis, Missouri, United States, 63131

Saint Louis Heart and Vascular

Saint Louis, Missouri, United States, 63136

United States, New Jersey

Cooper University Hospital

Camden, New Jersey, United States, 08103

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08901

United States, New York

Albany Associates in Cardiology

Albany, New York, United States, 12205

Montefiore Medical Center

Bronx, New York, United States, 10467

New York University Langone Medical Center

New York, New York, United States, 10016

Columbia University Medical Center

New York, New York, United States, 10032

Stony Brook University Hospital and Medical Center

Stony Brook, New York, United States, 11794-8167

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

The Sanger Clinic, PA

Charlotte, North Carolina, United States, 28203

Duke University Medical Center

Durham, North Carolina, United States, 27705

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45267

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44193

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

United States, Oklahoma

Oklahoma Heart Institute

Tulsa, Oklahoma, United States, 74104

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97201

Providence Saint Vincent Medical Center

Portland, Oregon, United States, 97225

United States, Pennsylvania

Geisinger Wyoming Valley Medical Center

Danville, Pennsylvania, United States, 17822-2160

Penn State University Cardiovascular Center

Hershey, Pennsylvania, United States, 17033

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States, 19102

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States, 19104

V.A. Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States, 15240

Lankenau Hospital

Wynnewood, Pennsylvania, United States, 19096

United States, South Carolina

Greenville Hospital System University Medical Center

Greenville, South Carolina, United States, 29605

United States, Tennessee

Memorial Health Care System

Chattanooga, Tennessee, United States, 37404

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

United States, Texas

Texas Cardiac Arrhythmia

Austin, Texas, United States, 78705

Baylor Heart and Vascular Hospital

Dallas, Texas, United States, 75226

Baylor All Saints Medical Center

Fort Worth, Texas, United States, 76104

University of Texas Health Science Center

Houston, Texas, United States, 77030

The Heart Hospital Baylor Plano

Plano, Texas, United States, 75093

South Texas Cardiovascular Consultants

San Antonio, Texas, United States, 78299

Scott and White Memorial Hospital

Temple, Texas, United States, 76508

United States, Utah

Intermountain Medical Center-LDS Hospital

Salt Lake City, Utah, United States, 84143

United States, Virginia

University of Virginia Health System

Charlottesville, Virginia, United States, 22908

Virginia Hospital Center - Arlington

Falls Church, Virginia, United States, 22042

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States, 23219

United States, Washington

Swedish Medical Center - Providence Campus

Seattle, Washington, United States, 98122

University of Washington Medical Center

Seattle, Washington, United States, 98195

Cardiac Study Center

Tacoma, Washington, United States, 98405

United States, Wisconsin

Waukesha Memorial Hospital

Waukesha, Wisconsin, United States, 53188

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Australia, Victoria

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Canada, Alberta

University of Calgary

Calgary, Alberta, Canada, T2N 2T9

Canada, Ontario

Hamilton Health Sciences

Hamilton, Ontario, Canada, L8L 2X2

University of Western Ontario - London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Southlake Regional Health Centre

Newmarket, Ontario, Canada, L3Y 8C3

China, Guangdong

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China, 510080

China, Jiangsu

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

China, Liaoning

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China, 116011

China

Beijing Anzhen Hospital

Beijing, China, 100029

Fuwai Hospital

Beijing, China, 100037

Czechia

Na Homolce Hospital

Prague 5, Hlavni Mesto Praha, Czechia, 150 30

Saint Anne's University Hospital, ICRC

Brno, Czechia, 65691

Charles University

Prague 2, Czechia, 12808

Clinic of Cardiology IKEM Medical Institute

Prague 4, Czechia, 14021

Germany

University Hospital of Mannheim

Mannheim, Baden-Wurttemberg, Germany, 68167

Klinikum Coburg

Coburg, Bayern, Germany, 96450

Universitares Herrzentrum Hamburg

Hamburg, Freie-Hansestadt Hamburg, Germany, 20246

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, Nordrhein-Westfalen, Germany, D-32545

Technische Universitat Dresden

Dresden, Saxony, Germany, D-01307

Kerckhoff Klinik

Bad Nauheim, Germany, D-61231

Praxisklinik Herz and GefaBe

Dresden, Germany, 01324

CCB - Cardioaniologisches Centrum Bethanien

Frankfurt, Germany, 60431

Georg-August-University

Gottingen, Germany, 37075

Asklepios Klinik St. Georg

Hamburg, Germany, 20099

Asklepios Klinik Barmbek

Hamburg, Germany, 22291

Saint Vincentius-Kliniken

Karlsruhe, Germany, 76137

Herzzentrum Leipzig

Leipzig, Germany, 04289

Universitat Rostock

Rostock, Germany, D-18057

Italy

Policlinico San Donato Center of Clinical Arrhythmia and Electrophysiology

San Donato Milanese, Lombardia, Italy, 20097

Policlinico Multimedical Cardiology and Arrhythmia Centre

Milan, Italy, 20099

Ospedale di Circolo e Fondazione Macchi

Varese, Italy, 21100

Korea, Republic of

Korea University Anam Hospital

Seoul, Korea, Republic of

Yonsei University Severance Hospital

Seoul, Korea, Republic of

Russian Federation

Research Institute of Circulation of Pathology

Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630055

Clinical Hospital # 83 under the Federal Medical and Biological Agency

Moscow, Russian Federation, 115682

Bakoulev Scientific Center for Cardiovascular Surgery

Moscow, Russian Federation, 121552

Scientific Research Institute of Cardiology of Ministry of Health of Russian Foundation

Tomsk, Russian Federation, 634012

United Kingdom

Golden Jubilee Hospital

Glasgow, United Kingdom, G81 4HX

Saint Bartholomew's Hospital

London, United Kingdom, EC1A 7BE

Saint George's Hospital Medical School

London, United Kingdom, SW17 0QT

Saint Mary's Hospital

London, United Kingdom, W2 1NY

Sponsors and Collaborators

Mayo Clinic

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)

  Study Documents (Full-Text)

Documents provided by Douglas L. Packer, MD, Mayo Clinic:

Study Protocol  [PDF] November 22, 2013

Statistical Analysis Plan  [PDF] February 26, 2018

More Information

Additional Information:

Mayo Clinic Clinical Trials 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Douglas L. Packer, MD, MD, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00911508
• Other Study ID Numbers: 09-004616; U01HL089709 ( U.S. NIH Grant/Contract )
• First Posted: June 2, 2009
• Results First Posted: August 26, 2019
• Last Update Posted: April 21, 2021
• Last Verified: April 2021

Keywords provided by Douglas L. Packer, MD, Mayo Clinic:

Atrial Fibrillation; Left Atrial Ablation; Pulmonary Vein Isolation; Catheter Ablation; Antiarrhythmic Drug Therapy

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes