Tailored Treatment of Permanent Atrial Fibrillation

INCLUSION CRITERIA

• History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.
• Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance
• Age between 18 and 70 years
• Failure of at least one Class I or III rhythm control drug
• Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

EXCLUSION CRITERIA

• Structural heart disease of clinical significance including:
• Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)
• Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction 55 mm
• Moderate to severe mitral or aortic valvular heart disease
• Stable/unstable angina or ongoing myocardial ischemia
• Myocardial infarction (MI) within 3 months of enrollment
• Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
• Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach
• Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)
• Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on Doppler echo)
• Any prior ablation for atrial fibrillation
• Enrollment in any other ongoing arrhythmia study
• Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
• Active infection or sepsis
• Any history of cerebral vascular disease including stroke or transient ischemic attacks
• Pregnancy or lactation
• Left atrial thrombus at the time of ablation
• Untreatable allergy to contrast media
• Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
• History of blood clotting (bleeding or thrombotic) abnormalities
• Known sensitivities to heparin or warfarin
• Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1)
• Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate