Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

The purpose of the trial is to compare two different approved treatments for recently
diagnosed AF: anti-arrhythmic medications and AF ablation. The study will be conducted to
determine if one treatment is more effective than the other for patients with AF and heart
failure. About 220 subjects with newly diagnosed AF from hospitals in the United States will
take part in this study. Subjects will be randomized in a 1:1 fashion to either AF catheter
ablation or anti-arrhythmic medication for treatment of AF. Both therapies are considered
Standard of Care.

Inclusion Criteria:

- must be 18 years of age or older

- Provide signed written Informed Consent

- symptomatic AF documented by EKG or heart rhythm monitoring within 12 months

- patients should be on optimal medical therapy for heart failure for 3 months prior to
randomization. Adjustments to medications within this 3 month period are permitted.

- chronically impaired LV function defined as EF between 20%-45% within last 3 months

- all patients should be on an optimal therapy for impaired LV function

- ability to complete 6 minute walk test

- eligible for catheter ablation and anti-arrhythmic drugs

Exclusion Criteria:

- women of childbearing potential unless post- menopausal or surgically sterile

- patients hospitalized for heart failure within the 3 months prior to randomization

- reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol
intoxication, recent major surgical procedures or trauma

- recent reversible LV impairment that may be attributed to AF with rapid ventricular
response and may improve with introduction of rate control

- valvular heart disease requiring surgical intervention

- Coronary Artery Disease (CAD) requiring surgical or percutaneous intervention

- early post-operative AF (within 3 months of surgery)

- previous MAZE or left atrial instrumentation (including ablation and left atrial
appendage exclusion)

- history of Atrioventricular Node (AVN) ablation

- hypertrophic cardiomyopathy

- prolonged QT interval

- liver failure

- renal failure requiring dialysis

- social factors that would preclude follow up or make compliance difficult- history of
drug, alcohol or substance abuse

- contraindications to the use of AADs and/or anticoagulation therapy

- Currently enrolled in, or discontinued within the last 30 days from a clinical trial
involving an investigational product or non-approved use of a drug or device or
concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study.

- severe pulmonary disease

- documented intra-atrial thrombus, tumor, or structural abnormality which precludes
catheter introduction

- unwilling to comply with protocol requirements or deemed by the investigator to be
unfit for the study.