Trials / Terminated
TerminatedNCT00721149
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial evaluates the safety and effectiveness of catheter ablation for PAF. 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 sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Radiofrequency Ablation | The Biosense Webster® NAVISTAR THERMOCOOL Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes. |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2008-07-23
- Last updated
- 2025-02-04
- Results posted
- 2014-01-22
Source: ClinicalTrials.gov record NCT00721149. Inclusion in this directory is not an endorsement.