A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
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Keep this study
Lead
Biosense Webster, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
