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Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial (CABANA)

This study has been completed.
Sponsor:
Collaborators:
Duke Clinical Research Institute
St. Jude Medical
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00578617
First received: December 14, 2007
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.


Condition Intervention
Atrial Fibrillation
Arrhythmia
 Drug: Rate Control
Device: Ablation Therapy
Drug: Rate control
Drug: Rhythm Control
Drug: Rhythm control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up [ Time Frame: 12 months after intervention ] [ Designated as safety issue: No ]
    Documentation of atrial fibrillation using a cardiac event recorder


Enrollment: 60
Study Start Date: September 2006
Study Completion Date: June 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pharmacologic Therapy
Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug.
 Drug: Rate Control
Metoprolol 50-100mg
Other Name: Toprol
Drug: Rate Control
Atenolol 50-100mg,
Other Name: Tenormin
Drug: Rate control
Propranolol 40-80mg
Other Name: Inderal
Drug: Rate control
Acebutolol 200mg
Other Name: Sectral
Drug: Rate control
Carvedilol 6.25mg
Other Name: Coreg
Drug: Rate Control
Diltiazem 180-240mg
Other Name: Cardizem
Drug: Rate Control
Verapamil 180-240mg
Other Name: Calan
Drug: Rate Control
Digoxin 0.125mg
Other Name: Lanoxin
Drug: Rhythm Control
Propafenone 450mg
Other Name: Rhythmol
Drug: Rhythm control
Flecainide 200mg
Other Name: Tambacor
Drug: Rhythm control
Sotalol 240mg
Other Name: Betapace
Drug: Rhythm control
Dofetilide 500mcg
Other Name: Tykosin
Drug: Rhythm control
Amiodarone 200mg
Other Name: Cordarone
Drug: Rhythm control
Quinidine 600-900mg
Other Name: Quini-glute/dex
Active Comparator: Ablation Therapy
Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
 Device: Ablation Therapy
Other Name: St. Jude: Livewire

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have documented AF, which warrants active drug or ablative treatment
  • Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs
  • Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4.5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography

Exclusion Criteria:

  • Previously failed 2 or more membrane active anti-arrhythmic drugs
  • Efficacy failure of a full dose Amiodarone trial of >12 weeks duration
  • Any amiodarone therapy in the past three months
  • Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
  • Lone atrial fibrillation in the absence of risk factors for stroke in patients <65 years of age
  • Recent cardiac events including myocardial infarction, percutaneous intervention, or valve or coronary bypass surgery in the preceding 3 months
  • Hypertrophic obstructive cardiomyopathy
  • Class IV angina or congestive heart failure
  • Planned heart transplantation
  • Other mandated anti-arrhythmic drug therapy
  • Heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare variety of ventricular tachycardia) with class I or III drugs
  • Prior left atrial catheter ablation with the intention to treat AF
  • Patients with other arrhythmias requiring ablative therapy
  • Prior surgical interventions for AF such as the MAZE procedure
  • Prior atrioventricular nodal ablation
  • Medical conditions limiting expected survival to <1 year
  • Contraindication to warfarin anti-coagulation
  • Women of childbearing potential
  • Participation in any other clinical mortality trial
  • Unable to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578617

Locations
United States, Alabama
Universtity of Alabama Hospital
Birminham, Alabama, United States, 35233
United States, California
Good Samaritan Hospital
Los Angeles, California, United States, 90017
United States, Illinois
Loyola University
Maywood, Illinois, United States, 60626
United States, Iowa
Mercy Medical Center
Des Moines, Iowa, United States, 50314
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania Health
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Mayo Clinic
Duke Clinical Research Institute
St. Jude Medical
Investigators
Principal Investigator: Douglas L. Packer, M.D. Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Douglas L. Packer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00578617     History of Changes
Other Study ID Numbers: 06-003867
Study First Received: December 14, 2007
Results First Received: July 20, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Atrial fibrillation
Left Atrial Ablation
Pulmonary Vein Isolation
Catheter Ablation
Antiarrhythmic Drug Therapy

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
 Calcium Channel Blockers
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013