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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
St. Jude Medical
Biosense Webster, Inc.
Information provided by (Responsible Party):
Douglas L. Packer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00911508
First received: May 28, 2009
Last updated: April 25, 2016
Last verified: April 2016
  Purpose
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 Intervention
Atrial Fibrillation
Arrhythmia
Device: Left atrial ablation
Drug: Rate or Rhythm Control Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • LA catheter ablation is superior to rate or rhythm control drug therapy for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients warranting therapy for AF. [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • LA catheter ablation is superior to rate or rhythm control drug therapy for reducing total mortality [ Time Frame: From date of enrollment until date of death ] [ Designated as safety issue: Yes ]
  • Total mortality or cardiovascular hospitalization [ Time Frame: From date of enrollment until date of death or CV hospitalization ] [ Designated as safety issue: Yes ]
  • Cardiovascular death [ Time Frame: From date of enrollment until date of death ] [ Designated as safety issue: Yes ]
  • Cardiovascular death or disabling stroke [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Arrhythmic death or cardiac arrest [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Heart failure death [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Freedom from recurrent AF [ Time Frame: From date of therapy initiation until date of first AF recurrence following a 90 day wait period ] [ Designated as safety issue: No ]
  • Cardiovascular hospitalization [ Time Frame: From date of enrollment until date of hospitalization ] [ Designated as safety issue: Yes ]
  • Medical costs, resource utilization, and cost effectiveness [ Time Frame: From date of enrollment through follow-up (average of 5 years) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: At months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 ] [ Designated as safety issue: No ]
  • Composite adverse events [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Left atrial size, morphology and function and its relationship to morbidity and mortality [ Time Frame: Baseline compared with 3-6 months post therapy initiation ] [ Designated as safety issue: No ]

Enrollment: 2204
Study Start Date: August 2009
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over the preceding 6 months have:

    1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) 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 BP >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, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ≥40 cc/m2), or 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 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, PCI, or valve or bypass surgery in the preceding 3 months
  • Hypertrophic obstructive cardiomyopathy (outflow track)
  • Class IV angina or Class IV CHF (including past or planned heart transplantation)
  • Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911508

  Hide Study 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, D.C., 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
St. 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
St. 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
St. Louis, Missouri, United States, 63131
Saint Louis Heart and Vascular
St. 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
News 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
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Oregon Health and Science University
Portland, Oregon, United States, 97201
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
Czech Republic
Na Homolce Hospital
Prague 5, Hlavni Mesto Praha, Czech Republic, 150 30
Saint Anne's University Hospital, ICRC
Brno, Czech Republic, 65691
Charles University
Prague 2, Czech Republic, 12808
Clinic of Cardiology IKEM Medical Institute
Prague 4, Czech Republic, 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 Barmbek
Hamburg, Germany, 22291
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
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)
St. Jude Medical
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)
  More Information

Additional Information:
Responsible Party: Douglas L. Packer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00911508     History of Changes
Other Study ID Numbers: 09-004616  U01HL089709 
Study First Received: May 28, 2009
Last Updated: April 25, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by 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
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on July 21, 2016