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NCT04133168 · ClinicalTrials.gov registry record · NA
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
A NA study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 458
- Enrollment target
NCT04133168: Completed NA study, sponsored by Boston Scientific Corporation.
NCT04133168 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 458 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04133168, a NA study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 458 participants
- Enrollment target
Study Summary
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
Primary Outcome
This measure reports the observed safety event-free rate at 12 Months follow up for all Non Roll-In treatment and intent subjects. The safety events are a composite of procedure-related and device-related adverse events. 7 days (Death, Myocardial infarction, Transient ischemic attack, Stroke/ Cerebrovascular accident, Vascular access complications, Mitral or tricuspid valvular damage, Thromboembolism/ Air embolism leading to a life-threatening event such as a ventricular arrhythmia, stroke, pulm
Interventions
- DEVICE Boston Scientific Cardiac Cryoablation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2023-08-17 |
| Phase | NA |
What the finished NCT04133168 record still lists
NCT04133168 is an interventional study that assigns participants to a tested intervention. The registered 458 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 (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Boston Scientific Cardiac Cryoablation System is the first listed.
NCT04133168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04133168 about?
NCT04133168 is a clinical study titled "Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation". To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
What is the current status of trial NCT04133168?
This trial is currently completed. It is a NA study. The enrollment target is 458 participants. The study started on 2020-06-24. Estimated completion is 2023-08-17.
What interventions are being tested in trial NCT04133168?
The interventions under investigation include: Boston Scientific Cardiac Cryoablation System (DEVICE).
Who is sponsoring clinical trial NCT04133168?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04133168's enrollment target sits among peer trials
458 224th of 2000 higher than 1,777 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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