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NCT00116428 · ClinicalTrials.gov registry record · Phase 3
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
A Phase 3 study, sponsored by Biosense Webster.
- Completed
- Registry status
- Phase 3
- Development phase
- 167
- Enrollment target
NCT00116428: Completed Phase 3 study, sponsored by Biosense Webster.
NCT00116428 is a Phase 3 study that has completed, run by Biosense Webster. The registered enrollment target is 167 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116428, a Phase 3 study, has completed, sponsored by Biosense Webster.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 167 participants
- Enrollment target
Study Summary
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Primary Outcome
Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.
Interventions
- DRUG Antiarrhythmic drug
- DEVICE NAVISTAR® THERMOCOOL® Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2004-10-01 |
| Est. Completion | 2011-03-01 |
| Phase | Phase 3 |
What the finished NCT00116428 record still lists
NCT00116428 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Antiarrhythmic drug is the first listed.
NCT00116428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116428 about?
NCT00116428 is a clinical study titled "NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation". This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercia...
What is the current status of trial NCT00116428?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2004-10-01. Estimated completion is 2011-03-01.
What interventions are being tested in trial NCT00116428?
The interventions under investigation include: Antiarrhythmic drug (DRUG), NAVISTAR® THERMOCOOL® Catheter (DEVICE).
Who is sponsoring clinical trial NCT00116428?
This trial is sponsored by Biosense Webster, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116428's enrollment target sits among peer trials
167 1463rd of 2000 higher than 538 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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