Electrophysiology - OMNY-AF

Prospective, single-arm, multi-center, clinical evaluation of the Biosense Webster (BWI) OMNYPULSE™ Pulsed Field Ablation (PFA) Platform to demonstrate safety and long-term effectiveness of the system for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Criteria:
Inclusion:

  1. 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
  2. Failed at least one Class I or Class III antiarrhythmic drug
  3. Willing and capable to provide consent
  4. Able and willing to comply with all pre-, post- and follow-up testing and requirements
  5. Adults age 18-80 years old

Exclusion: 

  1. Previously diagnosed with persistent AF (> 7 days in duration)
  2. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g., untreated documented obstructive sleep apnea and acute alcohol toxicity).
  3. Previous surgical or catheter ablation for AF
  4. Patients known to require ablation outside the PV ostia and outside the CTI region (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson White)
  5. Documented severe dilatation of the LA (LAD >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.
  6. Documented LA thrombus by imaging within 48 hours of the procedure.
  7. Documented severely compromised LVEF (LVEF <40%) by imaging within 6 months prior to enrollment.
  8. Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
  9. History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran),
  10. Documented thromboembolic event (including TIA) within the past 6 months.
  11. Previous PCI/MI within the past 2 months
  12. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)
  13. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve).
  14. Unstable angina within 6 months
  15. Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.
  16. Significant pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms.
  17. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  18. Prior diagnosis of pulmonary vein stenosis
  19. Pre-existing hemi diaphragmatic paralysis
  20. Acute illness, active systemic infection, or sepsis
  21. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
  22. Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)
  23. 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.
  24. Presence of a condition that precludes vascular access (such as IVC filter)
  25. Current enrollment in an investigational study evaluating another device or drug.
  26. 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.
  27. Life expectancy less than 12 months
  28. Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU).

Location: Hartford Hospital
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT06455098
Sponsor: Biosense Webster 
Contact: Saskia Campbell 860-972-2196 Saskia.Campbell@hhchealth.org