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

Paroxysmal Atrial Fibrillation Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

• NCT number: NCT00584415
• Study type: Interventional
• Source: University of Oklahoma
• Status: Completed
• Phase: N/A
• Start date: February 2004
• Completion date: February 2009