At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 437 enrolled
Drug / intervention
Atrial fibrillation ablationprocedure
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.
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Registry
In Brief
A Phase 4 clinical trial evaluating Atrial fibrillation ablation for Paroxysmal Atrial Fibrillation. Completed, enrolled 437 participants.
Detailed Summary
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Atrial Fibrillation
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartSep 2009
Primary CompletionSep 2013
Study CompletionJan 2018
TodayJul 2026
First PostedAug 24, 2009
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2013
Study CompletionJan 5, 2018
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.9 years ago
Interventions
Atrial fibrillation ablationprocedure
Radiofrequency ablation