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Clinical Trial

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

NCT: NCT06455098 · ACTIVE_NOT_RECRUITING

NCT IDNCT06455098
StatusACTIVE_NOT_RECRUITING
Start Date2024-06-28
Completion2027-07-31
SponsorBiosense Webster, Inc. (INDUSTRY)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)?

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) is a clinical trial registered under NCT06455098. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT06455098?

The current status of NCT06455098 (A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)) is: ACTIVE_NOT_RECRUITING.

When did A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) start?

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) started on 2024-06-28.

Related Devices

PMA P210027Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillationBiosense Webster, Inc. PMA P240006Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible ElectroporationBiosense Webster, Inc. PMA P010068catheter, percutaneous, cardiac ablation, for treatment of atrial flutterBiosense Webster, Inc. PMA P030031catheter, percutaneous, cardiac ablation, for treatment of atrial flutterBiosense Webster, Inc. PMA P040036Cardiac ablation percutaneous catheterBiosense Webster, Inc.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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