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NCT05293639 · ClinicalTrials.gov registry record · NA
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
A NA study, sponsored by Biosense Webster.
- Completed
- Registry status
- NA
- Development phase
- 362
- Enrollment target
NCT05293639: Completed NA study, sponsored by Biosense Webster.
NCT05293639 is a NA study that has completed, run by Biosense Webster. The registered enrollment target is 362 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05293639, a NA study, has completed, sponsored by Biosense Webster.
- COMPLETED
- Registry status
- NA
- Development phase
- 362 participants
- Enrollment target
Study Summary
To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/Cerebrovascular accident (CVA), Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency)
Interventions
- DEVICE Pulse Field Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2022-04-18 |
| Est. Completion | 2023-12-11 |
| Phase | NA |
What the finished NCT05293639 record still lists
NCT05293639 is an interventional study that assigns participants to a tested intervention. The registered 362 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 (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Pulse Field Ablation is the first listed.
NCT05293639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05293639 about?
NCT05293639 is a clinical study titled "Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System". To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation.
What is the current status of trial NCT05293639?
This trial is currently completed. It is a NA study. The enrollment target is 362 participants. The study started on 2022-04-18. Estimated completion is 2023-12-11.
What interventions are being tested in trial NCT05293639?
The interventions under investigation include: Pulse Field Ablation (DEVICE).
Who is sponsoring clinical trial NCT05293639?
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 NCT05293639's enrollment target sits among peer trials
362 284th of 2000 higher than 1,717 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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