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 <40% measured by acceptable cardiac testing

- Left atrial diameter >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