At a glance
ClinicalIndex Comparison RecordN/ACompleted· 119 enrolled
Drug / intervention
GP ablation + PV isolationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
In Brief
A clinical study evaluating GP ablation + PV isolation for Paroxysmal Atrial Fibrillation. Completed, enrolled 119 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2004
First PostedJan 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedJan 2, 2008
Enrollment StartFeb 1, 2004
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 18.5 years ago
Interventions
GP ablation + PV isolationdevice
All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter