Trials / Recruiting
RecruitingNCT06455098
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OMNYPULSE™ Catheter with the TRUPULSE Generator | OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation. |
Timeline
- Start date
- 2024-06-28
- Primary completion
- 2026-05-30
- Completion
- 2026-06-30
- First posted
- 2024-06-12
- Last updated
- 2026-03-13
Locations
46 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06455098. Inclusion in this directory is not an endorsement.