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Atrial FibrillationCABANANCT00911508

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

A study testing Left atrial ablation in people with Atrial Fibrillation and Arrhythmia, run by Mayo Clinic at 118 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Atrial Fibrillation, Arrhythmia
What is being tested?
Left atrial ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,204 participants
Where
118 sitesin 10 countries
Study dates
13 Nov 2009to 31 Dec 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Over the preceding 6 months have:
  • ≥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
  • electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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.

Trial locations and contacts

118 sites in 10 countries.

118 sites in 10 countries

United States76 sites

  • Albany Associates in Cardiology

    Albany, New York, 12205

  • Georgia Regents University

    Augusta, Georgia, 30912

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Alexian Brothers Medical Center

    Barrington, Illinois, 60010

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • The Sanger Clinic, PA

    Charlotte, North Carolina, 28203

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Memorial Health Care System

    Chattanooga, Tennessee, 37404

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44193

  • Penrose Saint Francis Health Services

    Colorado Springs, Colorado, 80907

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Geisinger Wyoming Valley Medical Center

    Danville, Pennsylvania, 17822-2160

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Virginia Hospital Center - Arlington

    Falls Church, Virginia, 22042

  • Baylor All Saints Medical Center

    Fort Worth, Texas, 76104

  • Greenville Hospital System University Medical Center

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Hartford Hospital

    Hartford, Connecticut, 06115

  • Penn State University Cardiovascular Center

    Hershey, Pennsylvania, 17033

  • University of Texas Health Science Center

    Houston, Texas, 77030

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • Arkansas Cardiology, PA

    Little Rock, Arkansas, 72205

  • Good Samaritan Hospital

    Los Angeles, California, 90017

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Georgia Arrhythmia Consultants & Research Institute

    Macon, Georgia, 31201

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Miami Hospital

    Miami, Florida, 60612

  • Minneapolis V.A. Medical Center

    Minneapolis, Minnesota, 55417

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • New York University Langone Medical Center

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Florida Hospital

    Orlando, Florida, 32803

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • V.A. Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Oregon Health and Science University

    Portland, Oregon, 97201

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23219

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Park Nicollet Methodist Hospital

    Saint Louis Park, Minnesota, 55426

  • Intermountain Medical Center-LDS Hospital

    Salt Lake City, Utah, 84143

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78299

  • University of California at San Francisco Medical Center

    San Francisco, California, 94143

  • Swedish Medical Center - Providence Campus

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Saint John's Mercy Heart Health Center

    St Louis, Missouri, 63131

  • Saint Louis Heart and Vascular

    St Louis, Missouri, 63136

  • Northside Hospital and Heart Institute

    St. Petersburg, Florida, 33709

  • Stanford University Medical Center

    Stanford, California, 94305

  • Stony Brook University Hospital and Medical Center

    Stony Brook, New York, 11794-8167

  • Cardiac Study Center

    Tacoma, Washington, 98405

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Florida Heart Rhythm-University of South Florida College of Medicine

    Tampa, Florida, 33606

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Mercy Medical Center-Iowa Heart Center

    West Des Moines, Iowa, 50226

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Saint Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

Germany14 sites

  • Kerckhoff Klinik

    Bad Nauheim, D-61231

  • Herz-und Diabeteszentrum NRW

    Bad Oeynhausen, North Rhine-Westphalia, D-32545

  • Klinikum Coburg

    Coburg, Bavaria, 96450

  • Technische Universitat Dresden

    Dresden, Saxony, D-01307

  • Praxisklinik Herz and GefaBe

    Dresden, 01324

  • CCB - Cardioaniologisches Centrum Bethanien

    Frankfurt, 60431

  • Georg-August-University

    Göttingen, 37075

  • Universitares Herrzentrum Hamburg

    Hamburg, Freie-Hansestadt Hamburg, 20246

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Saint Vincentius-Kliniken

    Karlsruhe, 76137

  • Herzzentrum Leipzig

    Leipzig, 04289

  • University Hospital of Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Universitat Rostock

    Rostock, D-18057

Other trials in Germany

China5 sites

  • Beijing Anzhen Hospital

    Beijing, 100029

  • Fuwai Hospital

    Beijing, 100037

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

Canada4 sites

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • University of Western Ontario - London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 8C3

Other trials in Canada

Czechia4 sites

  • Saint Anne's University Hospital, ICRC

    Brno, 65691

  • Na Homolce Hospital

    Prague, Prague, 150 30

  • Charles University

    Prague, 12808

  • Clinic of Cardiology IKEM Medical Institute

    Prague, 14021

Other trials in Czechia

Russia4 sites

  • Clinical Hospital # 83 under the Federal Medical and Biological Agency

    Moscow, 115682

  • Bakoulev Scientific Center for Cardiovascular Surgery

    Moscow, 121552

  • Research Institute of Circulation of Pathology

    Novosibirsk, Novosibirsk Oblast, 630055

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

    Tomsk, 634012

Other trials in Russia

United Kingdom4 sites

  • Golden Jubilee Hospital

    Glasgow, G81 4HX

  • Saint Bartholomew's Hospital

    London, EC1A 7BE

  • Saint George's Hospital Medical School

    London, SW17 0QT

  • Saint Mary's Hospital

    London, W2 1NY

Other trials in United Kingdom

Italy3 sites

  • Policlinico Multimedical Cardiology and Arrhythmia Centre

    Milan, 20099

  • Policlinico San Donato Center of Clinical Arrhythmia and Electrophysiology

    San Donato Milanese, Lombardy, 20097

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Australia2 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

South Korea2 sites

  • Korea University Anam Hospital

    Seoul

  • Yonsei University Severance Hospital

    Seoul

Other trials in South Korea

About this study

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.

Read the 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.

Being tested
Left atrial ablation, Rate or Rhythm Control Therapy
Keywords
Atrial Fibrillation, Left Atrial Ablation, Pulmonary Vein Isolation, Catheter Ablation, Antiarrhythmic Drug Therapy
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left atrial ablationDevice

    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 TherapyDrug

    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

Study groups in NCT00911508
Study groupRoleWhat they receive
Left Atrial AblationActive comparatorPulmonary 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.
Receives: Device: Left atrial ablation
Rate or Rhythm Control TherapyActive comparatorCurrent 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.
Receives: Drug: Rate or Rhythm Control Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From date of enrollment until time-to-first event over a median follow-up of 48.5 months.

Secondary outcomes (13)

  1. Number of Participants With All-cause Mortality

    All deaths were reviewed and adjudicated by the Clinical Events Committee

    Measured: From date of enrollment until date of death over a median follow-up of 48.5 months.

  2. 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.

    Measured: From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months.

  3. 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.

    Measured: 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.

  4. 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

    Measured: From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months.

  5. 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.

    Measured: 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.

  6. Number of Participants With an Arrhythmic Death or Cardiac Arrest

    All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee

    Measured: 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.

  7. Number of Participants With Heart Failure Death

    All deaths were categorized and adjudicated by the Clinical Events Committee

    Measured: From date of enrollment until date of heart failure death over a median follow-up of 48.5 months.

  8. 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.

    Measured: 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.

  9. 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.

    Measured: From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months.

  10. 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).

    Measured: Baseline ,12 month, 5 years

  11. 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).

    Measured: Baseline, 12 Month, 5 Year

  12. 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).

    Measured: Baseline, 12 Month, 5 Year

  13. 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.

    Measured: From treatment start date to date of event over a median follow-up of 48.5 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2009 (estimated)
  2. Study start13 Nov 2009
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911508
Sponsor's protocol ID
09-004616
Other IDs
U01HL089709
Acronym
CABANA
Status last verified
Apr 2021
First submitted
28 May 2009
Last updated
21 Apr 2021
Data monitoring committee
Yes

Publications

  • Zhao M, Chen Y, Li M, Jiang C, Wang Z, Liu H, He L, Sang C, Du X, Dong J, Packer DL, Ma C, Lip GYH. Impact of diagnosis to ablation time on clinical outcomes in patients with atrial fibrillation: post hoc analysis of the CABANA trial. BMC Med. 2026 Jan 12;24(1):81. doi: 10.1186/s12916-026-04615-3.

    PubMed 41526927

  • Wu Q, Wang L, Li Y, Liang Z, Li Q, Liu X, Yin Y, Liu Y, Hu Z, Gao H, Zhang T, Wang Y. Prognostic impact of mitral regurgitation in elderly patients with atrial fibrillation: results from the CABANA trial. Open Heart. 2025 Nov 27;12(2):e003478. doi: 10.1136/openhrt-2025-003478.

    PubMed 41314687

  • Chen Y, Soler-Espejo E, Zhao M, Li W, Liu H, Gue Y, McDowell G, Packer DL, Lip GYH. Association between comorbidity burden and outcomes of catheter ablation vs. medical therapy for atrial fibrillation: insights from the CABANA trial. Europace. 2025 Dec 1;27(12):euaf292. doi: 10.1093/europace/euaf292.

    PubMed 41213867

  • 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.

    PubMed 40839264

  • 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.

    PubMed 40645418

  • 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.

    PubMed 40243977

  • 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.

    PubMed 38629286

  • 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.

    PubMed 38307365

  • 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.

    PubMed 36688367

  • 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.

    PubMed 35640922

  • 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.

    PubMed 34933570

  • 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.

    PubMed 34238436

  • 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.

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Questions about this trial

What is this clinical trial studying?

A study testing Left atrial ablation in people with Atrial Fibrillation and Arrhythmia, run by Mayo Clinic at 118 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Germany, China, Canada, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00911508, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.

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