Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation

Not Applicable

Completed

Brief Summary: 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 paroxysmal 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.

Detailed Description: The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow:

1. Isolation of the pulmonary 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 eliminate 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 autonomic ganglionated plexi (GP) will have lower recurrence of atrial fibrillation.

Recruitment & Eligibility

Inclusion Criteria

Age greater or equal to 18 years
At least one documented episode of atrial fibrillation (AF) within the previous 6 months.
Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of AF or adverse effect.
Informed consent obtained.

Exclusion Criteria

Left atrial thrombus
Acute myocardial infarction within eight (8) weeks
Atriotomy within eight (8) weeks
Decompensated heart failure (unless the AF is thought to be a significant etiologic factor and AF ablation is clinically indicated)
Pregnancy
Ablation in a pulmonary vein within 4 months.
Occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
Enrolled in an investigational study evaluating another device or drug
Unwilling to participate in the study or unavailable for follow-up visits.
Incarcerated

Arm && Interventions

Group	Intervention	Description
GP + PVI ablation	GP ablation + PV isolation	This study contains only one arm, which is GP ablation + PV antrum isolation. The intervention (GP ablation + PV isolation) was performed using ThermoCool Navistar catheters in all patients

Primary Outcome Measures

Name	Time	Method
Atrial Tachyarrhythmia Recurrence in Participants	0-5 years	Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.

Secondary Outcome Measures

Name	Time	Method
Total Number of Significant Ablation Procedure Related Complications	0-1 year	Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke.