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A Study of OMNYPULSE Catheter for Paroxysmal Atrial Fibrillation

This study is testing the safety and effectiveness of a new treatment called BWI OMNYPULSE™ pulsed field ablation (PFA) for people with paroxysmal atrial fibrillation (PAF). PAF is an irregular heart rhythm that causes abnormal blood flow. The treatment uses the OMNYPULSE™ Catheter with the TRUPULSE™ Generator to isolate areas in the heart. We are looking for 440 participants, aged 18 to 80, who have symptomatic PAF and have not responded to at least one antiarrhythmic drug. The study will measure how many participants experience adverse events within 7 days and how many remain free from irregular heart rhythms for up to 12 months after the procedure. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 440 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for primary adverse events for 7 days after the procedure, and for freedom from atrial tachyarrhythmia for up to 365 days (12 months).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Active, Not Recruiting
NAAges 18–80InterventionalTreatment
Biosense Webster, Inc.
~353 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:OMNYPULSE™ Catheter with the TRUPULSE Generator

At a glance

Recruiting sites
0 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Primary Adverse Events (PAEs)
Measured over 7 days post-procedure
+1 more outcome measured

Conditions

Atrial Fibrillation

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NCT06455098

Where you'd take part

This study runs at 41 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advent Health Orlando

    Orlando, Floridano site contact published

  • Ascension St. Vincent's

    Jacksonville, Floridano site contact published

  • Baptist Health Research Institute

    Jacksonville, Floridano site contact published

  • Beaumont Health Systems

    Royal Oak, Michiganno site contact published

  • Brigham And Women's Hospital

    Boston, Massachusettsno site contact published

  • Cardiovascular Associates of Marin

    Larkspur, Californiano site contact published

  • Cleveland Clinic

    Cleveland, Ohiono site contact published

  • Emory Saint Joseph's Hospital

    Atlanta, Georgiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Biosense Webster, Inc. Clinical Trial · STUDY_DIRECTOR · Biosense Webster, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Diagnosed with symptomatic paroxysmal AF with:
Failed at least one Class I or Class III antiarrhythmic drug
Willing and capable to provide consent
Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion

Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
Previous surgical or catheter ablation for AF
Patients known to require ablation outside the PV ostia and outside the CTI region.
Documented severe dilatation of the left atrium (LAD\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
Documented severely compromised left ventricular ejection fraction (LVEF \<40%) by imaging within 6 months prior to enrollment
Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction \[MI\] within the past 2 months
Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
Valvular cardiac surgical/percutaneous procedure
Unstable angina within 6 months
Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Prior diagnosis of pulmonary vein stenosis
Pre-existing hemi diaphragmatic paralysis
Acute illness, active systemic infection, or sepsis
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
Severe mitral regurgitation
Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
Presence of a condition that precludes vascular access
Current enrollment in an investigational study evaluating another device or drug
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
Life expectancy less than 12 months
Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

What this trial measures

  • Number of Participants with Primary Adverse Events (PAEs)7 days post-procedure

    Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.

  • Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) EpisodesDay 91 to Day 365 post-procedure

    Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of \>= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported.