NCT00584415

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	GP ablation + PV isolation	All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter

Timeline

• Start date: 2004-02-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-01-02
• Last updated: 2014-07-28
• Results posted: 2014-07-28

Locations

1 site across 1 country: United States