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NCT01408485 · ClinicalTrials.gov registry record · NA
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT01408485: Completed NA study, sponsored by Abbott Medical Devices.
NCT01408485 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01408485, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
Primary Outcome
Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
Interventions
- DEVICE Therapy™ Cool Flex™ Irrigated Ablation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-10 |
| Phase | NA |
What the finished NCT01408485 record still lists
NCT01408485 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Therapy™ Cool Flex™ Irrigated Ablation System is the first listed.
NCT01408485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01408485 about?
NCT01408485 is a clinical study titled "Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter". To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
What is the current status of trial NCT01408485?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2011-11. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01408485?
The interventions under investigation include: Therapy™ Cool Flex™ Irrigated Ablation System (DEVICE).
Who is sponsoring clinical trial NCT01408485?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01408485's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 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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