A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Launched by BIOSENSE WEBSTER, INC. · Jun 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for a heart condition called paroxysmal atrial fibrillation (PAF), which causes an irregular heartbeat and can lead to poor blood flow. Researchers want to find out how safe and effective the BWI OMNYPULSE™ pulsed field ablation (PFA) platform is for isolating certain heart veins over a period of 12 months. The trial is currently looking for participants aged 65 to 74 who have experienced at least two episodes of symptomatic PAF in the last six months and have not found relief with at least one antiarrhythmic medication.

If you or a loved one are interested in participating, you should be willing to provide consent and follow the testing requirements throughout the study. However, certain conditions might make you ineligible, such as previous surgeries for AF, severe heart issues, or specific medical problems that could complicate the treatment. Participants can expect regular check-ups and monitoring to assess the safety and effectiveness of this new treatment approach.

Gender

ALL

Eligibility 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)