Ablation Versus Anti-Arrhythmic (AA) Drug Therapy for AF - Pivotal Trial
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation; Arrhythmia; Stroke Prevention; Mortality
Intervention: Left atrial ablation (Device); Rate or Rhythm Control Therapy (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Douglas L. Packer, M.D., Principal Investigator, Affiliation: Mayo Clinic
Kerry L. Lee, Ph.D., Principal Investigator, Affiliation: Duke University
Daniel B. Mark, M.D., MPH, Principal Investigator, Affiliation: Duke University
Rich A. Robb, Ph.D. Phy, Principal Investigator, Affiliation: Mayo Clinic
Alice M. Mascette, M.D., Study Chair, Affiliation: NIH/NHLBI
Overall contact:
Kristi H. Monahan, RN, BSM, Phone: 507-255-6676, Email: CABANA@mayo.edu
Summary
The 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 reducing total mortality in patients
with untreated or incompletely treated AF.
Clinical Details
Official title: Catheter Ablation Versus Anti-Arrhythmic Drug Therapy for Atrial Fibrillation Trial
Study design: Treatment, Randomized, Open Label, Parallel Assignment, 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 incompletely treated AF.
Secondary outcome: Decrease the composite endpoint of total mortality, disabling stroke, serious bleeding, and cardiac arrest in patients with untreated or incompletely treated AF warranting therapy.Total mortality, disabling stroke, serious bleeding, or cardiac arrest Total mortality or cardiovascular hospitalization Cardiovascular death Cardiovascular death or disabling stroke Arrhythmic death or cardiac arrest Heart failure deathLA size, morphology and function Freedom from recurrent AF Cardiovascular hospitalization Medical costs, resource utilization, and cost effectiveness Quality of Life Composite adverse events Left atrial size, morphology and function
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 3000 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Have the capacity to understand and sign an informed consent form
- Be ≥18 years of age.
- Have documented AF episodes ≥1 hour in duration; with ≥2 episodes over 4 months with
electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting
more than 1 week
- Warrant active therapy beyond simple ongoing observation
- Be eligible for both catheter ablation and ≥2 sequential rhythm control and/or ≥3
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, Prior stroke or TIA, LA
size ≥5. 0 cm (or volume index ≥40 cc/m2), or EF ≥35. Subjects <65 yrs of age whose
only risk factor is hypertension must have a second risk factor or LV hypertrophy to
qualify.
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
- More than one week of amiodarone treatment in the past 3 months
- An efficacy failure of full dose amiodarone treatment ≥12 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
- Class IV angina or Class IV CHF (including past or 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 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 warfarin anti-coagulation
- 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
- Unable to give informed consent
Locations and Contacts
Kristi H. Monahan, RN, BSM, Phone: 507-255-6676, Email: CABANA@mayo.edu
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Good Samaritan hospital, Los Angeles, California 90017, United States
Loyola University Medical Center, Maywood, Illinois 60153, United States
Iowa Heart Center, West Des Moines, Iowa 50226, United States
Johns Hopkins Hospital, Baltimore, Maryland 21287, United States
Brigham and Womens Hospital, Boston, Massachusetts 02115, United States
Mayo Clinic Rochester, Rochester, Minnesota 55905, United States
Ohio State University Medical Center, Columbus, Ohio 43210, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
LDS Hospital, Salt Lake City, Utah 84143, United States
Additional Information
Mayo Clinic Clinical Trials
Starting date: August 2009
Ending date: September 2015
Last updated: June 2, 2009
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