Official Title: “Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial”

CABANA 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 total mortality (primary endpoint) and decreasing the composite endpoint of total mortality, disabling stroke, serious bleeding and cardiac arrest (secondary endpoint) in patients with untreated or incompletely treated AF warranting therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

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 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 >3 rate control drugs. Pts will be followed every 6 months for >2 yrs 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.

Intervention(s) in this Clinical Trial

• Drug: Pharmacologic Therapy Rate and/or Rhythm Control
  • Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200mg, Carvedilol 6.25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125mg. Rhythm control: Propafenone 450mg, Flecainide 200mg, Sotalol 240mg, Dofetilide 500mcg, Amiodarone 200mg, Quinidine 600-900mg
• Device: NAVI-STAR Thermo-cool (Left Atrial Catheter Ablation)
  • St. Jude: Livewire, Therapy Dual / Thermocouple. Biosense Webster: NAVI-STAR/ NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-cool. CryoCath Technologies: Freezor/Freezor Max. Bard: Stinger. Boston Scientific: Blazer II RF/RPM/SteeroCath/XP, Chilli Cooled.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Pharmacologic Therapy Rate and/or Rhythm Control
• Active Comparator: 2
  • Left Atrial Catheter Ablation

Primary Measures

• Percutaneous left atrial catheter ablation for the purpose of eliminating AF is superior to current state-of-the-art therapy with either rate or rhythm control drugs for reducing total mortality in patients with untreated or under-treated AF.
  • Time Frame: Trial length
    Safety Issue?: Yes

Secondary Measures

• A composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest.
  • Time Frame: Trial length
    Safety Issue?: Yes
• Medical costs and resource utilization and cost effectiveness
  • Time Frame: Trial length
    Safety Issue?: No
• Composite adverse events
  • Time Frame: Trial length
    Safety Issue?: Yes
• Determine the impact of age, AF type, symptom state, and presence of underlying disease on these outcomes and establish the importance of AF elimination in this population of patients.
  • Time Frame: Trial length
    Safety Issue?: Yes
• Quality of Life
  • Time Frame: 3 months and annual
    Safety Issue?: No

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 TIA, Left atrium >4.5 cm, EF <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 MI, PCI, 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 with class I or III drugs
• Prior LA 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 AV 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Douglas L. Packer, M.D. Principal Investigator Mayo Clinic  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00578617

Study ID Number: 06-003867

ClinicalTrials.gov Identifier: NCT00578617

Health Authority: United States: Food and Drug Administration

Mayo Clinic Clinical Trials