OMNYPULSE Catheter for Atrial Fibrillation
(OMNY-AF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with paroxysmal atrial fibrillation (PAF), a condition where the heart beats irregularly, affecting blood flow. The study aims to determine the safety and effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform over 12 months. Participants will undergo a specific heart procedure to isolate pulmonary veins and treat PAF using a special catheter. Those who have experienced at least two episodes of symptomatic PAF in the past six months and have not responded to certain medications may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to pioneering research that could lead to new treatment options for PAF.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since participants must have failed at least one antiarrhythmic drug, you might need to continue or adjust your current medication. It's best to discuss this with the trial team.
What prior data suggests that the BWI OMNYPULSE™ pulsed field ablation platform is safe for pulmonary vein isolation?
Research has shown that the OMNYPULSE pulsed field ablation (PFA) system holds promise for safely treating paroxysmal atrial fibrillation (PAF). In earlier studies, the PFA catheter achieved 100% success and maintained a strong safety record, effectively working without causing serious side effects. Another study confirmed that a similar PFA catheter was safe and effective, with short procedure times and low radiation exposure.
These findings suggest that the OMNYPULSE system is well-tolerated by patients. It uses pulsed electrical energy to target and treat specific areas in the heart, and trials so far indicate it operates safely.12345Why are researchers excited about this trial?
Researchers are excited about the pulsed field ablation system for treating paroxysmal atrial fibrillation because it offers a novel approach compared to traditional treatments like radiofrequency or cryoablation. Unlike these methods, which use heat or extreme cold to create scar tissue in the heart, pulsed field ablation uses electrical pulses to selectively target and eliminate problematic heart tissue. This technique could potentially lead to fewer complications and quicker recovery times, making it an appealing alternative for patients. Additionally, the use of the OMNYPULSE™ catheter with the TRUPULSE™ generator is designed to improve precision and safety during the procedure.
What evidence suggests that the pulsed field ablation system is effective for paroxysmal atrial fibrillation?
Studies have shown that pulsed field ablation (PFA) effectively treats paroxysmal atrial fibrillation (PAF), a condition causing an irregular heartbeat. In one study, the OMNYPULSE catheter successfully met its immediate treatment goals in all cases without major safety concerns. Another study found that patients treated with PFA experienced long-term benefits, with many remaining free from atrial fibrillation for a year. This trial will evaluate the PFA procedure using the OMNYPULSE™ catheter combined with the TRUPULSE™ generator. The treatment uses a special type of energy to precisely target and isolate the heart areas causing the irregular rhythm.23678
Who Is on the Research Team?
Biosense Webster, Inc. Clinical Trial
Principal Investigator
Biosense Webster, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo pulsed field ablation procedure with the OMNYPULSE™ catheter for pulmonary vein isolation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BWI Pulsed Field Ablation with OMNYPULSE Catheter
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biosense Webster, Inc.
Lead Sponsor
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
One-year outcomes of a conformable single-shot pulsed ...
To determine 1-year outcomes of a single-shot, all-in-one mapping and ablation PFA catheter for treating paroxysmal atrial fibrillation (PAF).
Long-Term Clinical Benefits of Pulsed Field Ablation in ...
Clinical effectiveness of catheter ablation in atrial fibrillation (AF) is typically characterized by 12-month freedom from atrial ...
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 ...
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 ...
Pulsed Field Ablation for Persistent Atrial Fibrillation
The first large prospective study of PFA to treat PerAF using a strategy of PVI and posterior wall isolation, revealed favorable safety and effectiveness ...
Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation
ADMIRE confirmed the safety and effectiveness of the variable-loop PFA catheter, with short procedure and PFA application times and low fluoroscopy exposure.
Summary of Safety and Effectiveness Data (SSED)
Data from the outside US (OUS) study titled, “A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field. Ablation (PFA) ...
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.
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