Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation|
- Atrial Tachyarrhythmia Recurrence in Participants [ Time Frame: 0-5 years ] [ Designated as safety issue: Yes ]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.
- Total Number of Significant Ablation Procedure Related Complications [ Time Frame: 0-1 year ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2004|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Active Comparator: GP + PVI ablation
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
All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
Other Name: Navi-Star ThermoCool Catheter, Biosense-Webster Inc.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584415
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Sunny Po, MD||University of Oklahoma|