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NCT01401361 · ClinicalTrials.gov registry record · Phase 3
Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
A Phase 3 study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT01401361: Completed Phase 3 study, sponsored by Abbott Medical Devices.
NCT01401361 is a Phase 3 study that has completed, run by Abbott Medical Devices. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01401361, a Phase 3 study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter * Does not result into unacceptable risk of intra-procedural composite serious adverse events and, * Does not affect efficacy of the ablation procedure The study will also evaluate the
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 Treatment Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01401361 record still lists
NCT01401361 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment Arm is the first listed.
NCT01401361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01401361 about?
NCT01401361 is a clinical study titled "Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System". To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter * Does not result into unacceptable risk of intra-procedural composite serious adverse events and, * Does not affect ef...
What is the current status of trial NCT01401361?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2011-10. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01401361?
The interventions under investigation include: Treatment Arm (DEVICE).
Who is sponsoring clinical trial NCT01401361?
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 NCT01401361's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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