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NCT00584415 · ClinicalTrials.gov registry record · NA
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
A NA study, sponsored by University of Oklahoma.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
NCT00584415: Completed NA study, sponsored by University of Oklahoma.
NCT00584415 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00584415, a NA study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.
Interventions
- DEVICE GP ablation + PV isolation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2004-02 |
| Est. Completion | 2009-02 |
| Phase | NA |
What the finished NCT00584415 record still lists
NCT00584415 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which GP ablation + PV isolation is the first listed.
NCT00584415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00584415 about?
NCT00584415 is a clinical study titled "Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation". 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 a...
What is the current status of trial NCT00584415?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2004-02. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00584415?
The interventions under investigation include: GP ablation + PV isolation (DEVICE).
Who is sponsoring clinical trial NCT00584415?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00584415's enrollment target sits among peer trials
119 803rd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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