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NCT01639495 · ClinicalTrials.gov registry record · Phase 3
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
A Phase 3 study, sponsored by Biosense Webster.
- Completed
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
NCT01639495: Completed Phase 3 study, sponsored by Biosense Webster.
NCT01639495 is a Phase 3 study that has completed, run by Biosense Webster. The registered enrollment target is 148 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
NCT01639495, a Phase 3 study, has completed, sponsored by Biosense Webster.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 148 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
Primary Outcome
Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures
Interventions
- DEVICE THERMOCOOL® SMARTTOUCH™ Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2012-07-01 |
| Est. Completion | 2014-10-01 |
| Phase | Phase 3 |
What the finished NCT01639495 record still lists
NCT01639495 is an interventional study that assigns participants to a tested intervention. The registered 148 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 THERMOCOOL® SMARTTOUCH™ Catheter is the first listed.
NCT01639495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01639495 about?
NCT01639495 is a clinical study titled "THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS". This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
What is the current status of trial NCT01639495?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2012-07-01. Estimated completion is 2014-10-01.
What interventions are being tested in trial NCT01639495?
The interventions under investigation include: THERMOCOOL® SMARTTOUCH™ Catheter (DEVICE).
Who is sponsoring clinical trial NCT01639495?
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 NCT01639495's enrollment target sits among peer trials
148 1547th of 2000 higher than 451 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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