Recruiting

OMNY-AFBWI Pulsed Field Ablation System for Paroxysmal Atrial Fibrillation

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Study Aim

This study aims to see if the BWI Pulsed Field Ablation System can effectively treat paroxysmal atrial fibrillation by reducing episodes of irregular heartbeats and assess the safety regarding adverse events in participants.

What is being tested

OMNYPULSE™ Catheter with the TRUPULSE Generator

Device
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

From 18 to 80 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2024
See protocol details

Summary

Principal SponsorBiosense Webster, Inc.
Study ContactStudy Contact
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 28, 2024

Actual date on which the first participant was enrolled.

This study is evaluating a new treatment approach for people experiencing paroxysmal atrial fibrillation (PAF), a condition where the heart beats irregularly, affecting blood flow. The key focus is on the safety and effectiveness of the BWI OMNYPULSE™ pulsed field ablation system, a medical device used to isolate the pulmonary veins. By doing so, it aims to help manage the symptoms of PAF. This research is important because finding a safe and effective treatment can improve the quality of life for those with this heart condition. Participants in the study will undergo treatment using the pulsed field ablation system, which involves a procedure to disrupt irregular heart signals and restore normal rhythm. The treatment is delivered through a catheter, a thin tube inserted into the body. The study will monitor participants for 12 months to assess how well the treatment works and ensure it is safe. There are no specific risks or benefits mentioned, but like any medical procedure, there might be potential side effects that will be closely observed.

Official TitleAssessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
NCT06455098
Principal SponsorBiosense Webster, Inc.
Study ContactStudy Contact
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

440 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
Able and willing to comply with all pre-, post- and follow-up testing and requirements
Failed at least one Class I or Class III antiarrhythmic drug
Willing and capable to provide consent
27 exclusion criteria prevent from participating
Severe mitral regurgitation
Acute illness, active systemic infection, or sepsis
Current enrollment in an investigational study evaluating another device or drug
Patients known to require ablation outside the PV ostia and outside the CTI region.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 46 locations

Recruiting

Phoenix Cardiovascular Research Group

Phoenix, United StatesOpen Phoenix Cardiovascular Research Group in Google Maps
Recruiting

Mills Peninsula Health Services

Burlingame, United States
Recruiting

Cardiovascular Associates of Marin

Larkspur, United States
Recruiting

Hoag Memorial Hospital

Newport Beach, United States
Recruiting
46 Study Centers