OMNYPULSE Catheter + TRUPULSE Generator for Atrial Fibrillation

(Omny-IRE Trial)

No longer recruiting at 18 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biosense Webster, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Thyroid disease, Renal insufficiency, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system for treating paroxysmal atrial fibrillation (PAF), a condition where the heart beats irregularly, causing discomfort and health issues. The trial focuses on using an ablation system, which uses energy to scar heart tissue and stop faulty signals, targeting the area around the pulmonary veins. Participants with noticeable PAF symptoms who plan to undergo an ablation procedure are sought for this trial. The system under evaluation includes the OMNYPULSE Catheter and TRUPULSE Generator. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future PAF treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ablation system is safe for treating paroxysmal atrial fibrillation?

Research has shown that the OMNYPULSE Catheter and TRUPULSE Generator are safe for treating atrial fibrillation, an irregular heartbeat. In one study, all patients experienced immediate treatment success without serious problems. Another study found that the treatment remained effective and safe over a year. These results suggest that the treatment is generally well-tolerated by people with paroxysmal atrial fibrillation (PAF). ^{1 2 3 4 5}

Why are researchers excited about this trial?

The OMNYPULSE Catheter and TRUPULSE Generator stand out because they offer a more targeted and potentially efficient way to address atrial fibrillation by isolating the pulmonary veins using a bi-directional catheter combined with advanced energy delivery. Unlike traditional catheter ablation methods, which can be less precise, this combination aims to enhance the precision and effectiveness of the procedure, potentially resulting in better outcomes for patients with symptomatic paroxysmal atrial fibrillation. Researchers are excited because this could mean fewer complications and a quicker recovery time for patients compared to standard ablation techniques.

What evidence suggests that the OMNYPULSE Catheter and TRUPULSE Generator are effective for atrial fibrillation?

Research has shown that the OMNYPULSE Catheter and TRUPULSE Generator, used by participants in this trial, hold promise for treating paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat. In one study, all patients had their irregular heartbeat corrected immediately during the procedure, achieving a 100% success rate. Additionally, 84.5% of patients maintained successful treatment over time, preventing future irregular heartbeats. This indicates the treatment is effective both immediately and in the long term. Importantly, the treatment also proved very safe, alleviating concerns about potential risks. ^{1 2 5 6 7}

Who Is on the Research Team?

Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial

Principal Investigator

Biosense Webster, Inc., a division of Johnson & Johnson

Are You a Good Fit for This Trial?

This trial is for individuals with symptomatic paroxysmal atrial fibrillation (PAF) who are selected for a pulmonary vein isolation procedure. Participants must be able to consent and follow the study's requirements. Exclusions include those with certain heart conditions, implanted devices that interfere with the study, severe organ issues, or major health problems that could affect participation.

Inclusion Criteria

I have been diagnosed with a type of irregular heartbeat that stops on its own or with treatment within a week and causes me symptoms.

I am willing and able to give my consent.

Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria

You have a pre-existing neurological problem that has not been resolved.

I do not have any current infections or severe illnesses.

I have not had unstable chest pain in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ablation Procedure

Participants undergo the ablation procedure with the OMNYPULSE catheter and TRUPULSE generator for pulmonary vein isolation

Immediate

1 visit (in-person)

Post-procedure Monitoring

Participants are monitored for primary adverse events within 7 days following the ablation procedure

1 week

Effectiveness Evaluation

Participants are evaluated for freedom from atrial arrhythmia episodes from Day 91 to Day 365 post-procedure

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OMNYPULSE Catheter and TRUPULSE Generator

Trial Overview The trial tests the safety and effectiveness of an ablation system consisting of the OMNYPULSE Bi-directional catheter and TRUPULSE generator in isolating atrial pulmonary veins to treat PAF.

How Is the Trial Designed?

Group I: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator Experimental Treatment 1 Intervention

Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).

Who Is Running the Clinical Trial?

Biosense Webster, Inc.

Lead Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05971693

NCT05971693 | A Study For Treatment of Paroxysmal ... The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when ...

2. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2025/04/25/18/28/Omny-IRE

Omny-IRE: Novel OMNYPULSE Catheter Effective, Safe in ... The OMNYPULSE pulsed field ablation (PFA) catheter had a 100% acute success rate, paired with a strong safety profile, in treating paroxysmal atrial ...

3. jnj.com jnj.com/media-center/press-releases/johnson-johnson-medtech-presents-3-month-data-from-omny-ire-clinical-trial-at-2025-heart-rhythm-society-annual-meeting

Omny-IRE data demonstrated the investigational ... Omny-IRE data demonstrated the investigational OMNYPULSE™ Platform achieved 100% acute success and 84.5% pulmonary vein isolation (PVI) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06455098

NCT06455098 | A Study of Assessment on Safety and ... 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 ...

5. jacc.org jacc.org/doi/10.1016/j.jacep.2025.04.008

PVI With CF-Sensing Large-Tip Focal PFA Catheter With ... The Omny-IRE study was an interventional, prospective, multicenter, single-arm safety and effectiveness study using the OMNYPULSE Bidirectional ...

6. jnj.com jnj.com/media-center/press-releases/johnson-johnson-medtech-completes-pilot-phase-enrollment-of-omny-af-trial-evaluating-large-tip-focal-pulsed-field-ablation-omnypulse-catheter

The OMNY-AF trial evaluates safety and efficacy ... The investigational OMNYPULSE™ Platform uses pulsed electrical field energy to produce targeted intracardiac lesions for the treatment of AFib.

7. jnjmedtech.com jnjmedtech.com/en-US/news-events/johnson-johnson-medtech-presents-3-month-data-omny-ire-clinical-trial-2025-heart-rhythm

Johnson & Johnson MedTech Presents 3-Month Data from ... Omny-IRE data demonstrated the investigational OMNYPULSE™ Platform achieved 100% acute success and 84.5% pulmonary vein isolation (PVI) ...