Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
Completed · Not applicable
Conditions studied: Paroxysmal Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT00584415
- Run by
- University of Oklahoma
- People needed
- 119
- Starts
- 2004-02-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2014-07-28
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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