The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be
used to safely and effectively reduce symptomatic episodes of atrial fibrillation in
patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial
fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.
The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower
electrode-tissue interface temperture, combined with the anatomical guidance of
electroanatomical mapping should allow:
1. Isolation of the pumonary veins at the LA-PV junction with the same or lower risk of
pulmonary vein stenosis;
2. Creation of continuous, transmural linear left atrial lesions with the same or lower
risk of thromboembolism;
3. These two factors will elimate documented episodes of symptomatic sustained AF in
patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month);
4. Patients with interruption of the vagal response (sinus bradycardia or AV block) during
stimulation at the sites of left atrial automomic ganglionated plexi (GP) will have
lower recurrence of atrial fibrillation.
1. Age greater or equal to 18 years
2. At least one documented episode of atrial fibrillation (AF) within the previous 6
3. Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of
AF or adverse effect.
4. Informed consent obtained.
1. Left atrial thrombus
2. Acute myocardial infarction within eight (8) weeks
3. Atriotomy within eight (8) weeks
4. Decompensated heart failure (unless the AF is thought to be a significant etiologic
factor and AF ablation is clinically indicated)
6. Ablation in a pulmonary vein within 4 months.
7. Occurrence of perforation during an ablation procedure performed less than two months
prior to the planned ablation date.
8. Significant congenital anomaly or medical problem that, in the opinion of the
investigator, would preclude enrollment in the study.
9. Enrolled in an investigational study evaluating another device or drug
10. Unwilling to participate in the study or unavailable for follow-up visits.