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

Study Overview
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Brief Summary
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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
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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: Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of pulmonary vein stenosis; Creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism; These two factors will eliminate documented episodes of symptomatic sustained AF in patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month); 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.

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

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: GP ablation + PV isolation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GP + PVI ablation<br>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 | Device: GP ablation + PV isolation<br>* All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter<br>* Other names: Navi-Star ThermoCool Catheter, Biosense-Webster Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Tachyarrhythmia Recurrence in Participants | 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. | 0-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Significant Ablation Procedure Related Complications | 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. | 0-1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter Ablation, Atrial Fibrillation