Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation; Arrhythmia; Stroke Prevention; Mortality
Intervention: Pharmacologic Therapy Rate and/or Rhythm Control (Drug); NAVI-STAR Thermo-cool (Left Atrial Catheter Ablation) (Device)
Phase: Phase 3
Sponsored by: Mayo Clinic
Official(s) and/or principal investigator(s):
Douglas L. Packer, M.D., Principal Investigator, Affiliation: Mayo Clinic
Kristi H Monahan, RN, BA, Phone: 507-255-7456, Email: CABANA@mayo.edu
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.
Official title: Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
A composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest.
Medical costs and resource utilization and cost effectiveness
Composite adverse events
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.
Quality of Life
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
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.
Minimum age: 18 Years.
Maximum age: 90 Years.
- 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
- 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
- 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
Locations and Contacts
Kristi H Monahan, RN, BA, Phone: 507-255-7456, Email: CABANA@mayo.edu
Mayo Clinic, Rochester, Minnesota 55902, United States; Recruiting
Kristi H. Monahan, RN, BA, Phone: 507-255-7456, Email: CABANA@mayo.edu
Douglas L. Packer, M.D., Principal Investigator
David Bradley, M.D., Sub-Investigator
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Starting date: September 2006
Ending date: January 2008
Last updated: December 20, 2007