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

Exploring a new treatment option for irregular heartbeats (PAF).

Recruiting
18-80 years
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is testing if a new device called **OMNYPULSE™ pulsed field ablation (PFA)** is safe and works well to help people with **paroxysmal atrial fibrillation (PAF)**. PAF is when your heart beats in an irregular way, which can affect blood flow. The study aims to see how effective the device is over 12 months.

To join the study, you need to have had symptoms of PAF at least twice in the last 6 months and need to have tried at least one medicine for it that didn't work. You also have to agree to all tests and follow-ups required by the study. You cannot join if you have other heart problems, are pregnant, or have been in a similar study recently.

  • The study will last for 12 months.
  • Participants will need to attend regular follow-up visits.
  • It is important to consider any risks and benefits before joining.

This study is important to find new ways to treat PAF safely and effectively. If you think you qualify and are interested, contact the study organizers for more information.

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Study details
    Atrial Fibrillation

NCT06455098

Biosense Webster, Inc.

28 June 2025

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