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NCT00318565 · ClinicalTrials.gov registry record · Phase 4
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
A Phase 4 study, sponsored by Biosense Webster.
- Completed
- Registry status
- Phase 4
- Development phase
- 291
- Enrollment target
NCT00318565: Completed Phase 4 study, sponsored by Biosense Webster.
NCT00318565 is a Phase 4 study that has completed, run by Biosense Webster. The registered enrollment target is 291 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00318565, a Phase 4 study, has completed, sponsored by Biosense Webster.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 291 participants
- Enrollment target
Study Summary
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
Primary Outcome
Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
Interventions
- DEVICE RF energy delivery for treatment of Typical Atrial flutter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
What the finished NCT00318565 record still lists
NCT00318565 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 1 intervention - of which RF energy delivery for treatment of Typical Atrial flutter is the first listed.
NCT00318565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00318565 about?
NCT00318565 is a clinical study titled "Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter". The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
What is the current status of trial NCT00318565?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 291 participants. The study started on 2006-01. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00318565?
The interventions under investigation include: RF energy delivery for treatment of Typical Atrial flutter (DEVICE).
Who is sponsoring clinical trial NCT00318565?
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 NCT00318565's enrollment target sits among peer trials
291 297th of 2000 higher than 1,704 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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