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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 is a Phase 3 study that has completed, run by Biosense Webster. The registered enrollment target is 167 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00116428
The ClinicalTrials.gov registry entry for NCT00116428 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosense Webster, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Antiarrhythmic drug is the first listed.
NCT00116428 reports 0 study locations.
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.
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