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Assessing the safety and effectiveness of a new catheter for treating paroxysmal atrial fibrillation

Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter

Not applicable Interventional Biosense Webster, Inc. · NCT06455098

This study is testing a new catheter to see if it can safely help people with paroxysmal atrial fibrillation feel better by improving their heart rhythm after other treatments haven't worked.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment440 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorBiosense Webster, Inc. Industry-sponsored
Locations46 sites (Phoenix, Arizona and 45 other locations)
Trial IDNCT06455098 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the BWI OMNYPULSE™ pulsed field ablation platform for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation. Participants must have experienced multiple episodes of atrial fibrillation and have failed at least one antiarrhythmic drug. The intervention involves using the OMNYPULSE™ Catheter along with the TRUPULSE Generator to treat the condition. The study aims to demonstrate significant improvements in heart rhythm over a 12-month period.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with symptomatic paroxysmal atrial fibrillation who have experienced at least two episodes in the last six months and have failed previous antiarrhythmic treatments.

Not a fit: Patients with persistent atrial fibrillation or those who have had prior surgical or catheter ablation for atrial fibrillation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for patients suffering from paroxysmal atrial fibrillation.

How similar studies have performed: Other studies have shown promise with pulsed field ablation techniques, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosed with symptomatic paroxysmal AF with:

  1. At least two symptomatic AF episodes within last six months from enrollment
  2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment
* 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 Criteria:

* 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)

Where this trial is running

Phoenix, Arizona and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrial Fibrillation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.