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NCT02217254 · ClinicalTrials.gov registry record · NA
The OneFreeze Study
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT02217254: Completed NA study, sponsored by University of California, San Francisco.
NCT02217254 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02217254, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
The One Freeze study is a prospective multi-center randomized controlled trial to assess the safety and efficacy of one vs. two cryoablations per pulmonary vein for the treatment of atrial fibrillation.
Primary Outcome
Composite score of adverse events (Range 0-20 points) will be calculated after the patient has completed follow-up. Higher scores indicate greater severity. Luminal Esophageal Temperature (LET) (0-2 points): 1-point if ≤20 degrees C, 2-points if ≤15 degrees C Phrenic nerve injury (0-3 points): 1-point if ≥30% decrease in compound muscle action potential (CMAP) or loss of phrenic nerve capture resulting in cessation of freeze (without movement of pacing catheter), 2-points if Phrenic nerve pals
Interventions
- PROCEDURE Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2014-10 |
| Est. Completion | 2019-10 |
| Phase | NA |
What the finished NCT02217254 record still lists
NCT02217254 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System is the first listed.
NCT02217254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02217254 about?
NCT02217254 is a clinical study titled "The OneFreeze Study". The One Freeze study is a prospective multi-center randomized controlled trial to assess the safety and efficacy of one vs. two cryoablations per pulmonary vein for the treatment of atrial fibrillation.
What is the current status of trial NCT02217254?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2014-10. Estimated completion is 2019-10.
What interventions are being tested in trial NCT02217254?
The interventions under investigation include: Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System (PROCEDURE).
Who is sponsoring clinical trial NCT02217254?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02217254's enrollment target sits among peer trials
90 941st of 2000 higher than 1,029 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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