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Ablation Versus Anti-Arrhythmic (AA) Drug Therapy for AF - Pivotal Trial - NCT00911508-23219(Clinical Trial 547161)



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City:  Richmond
State:  
VA
Zip Code: 23219
Conditions: Atrial Fibrillation - Arrhythmia - Stroke Prevention - Mortality
Purpose: 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.
Study summary: 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.
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
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: December 15, 2010
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