Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation

Ki vehet részt

• Symptomatic paroxysmal or persistent atrial fibrillation documented by:; A physician's note indicating recurrent AF; At least two electrocardiographically documented AF episodes within 12 months prior to enrollment
• Failure or intolerance of at least one Class I-IV anti-arrhythmic drug
• Suitable candidate for catheter ablation
• Age ≥ 18 and < 75 years
• Able and willing to give informed consent
• Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements

Ki nem vehet részt

• Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure)
• Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure
• Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure
• Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure
• Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor
• Known drug or alcohol dependency
• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause
• Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
• Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure
• Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days)
• History of blood clotting or bleeding abnormalities
• Any condition contraindicating chronic anticoagulation
• Uncontrolled heart failure or NYHA Class III or IV heart failure
• Rheumatic heart disease
• Unstable angina
• Primary pulmonary hypertension
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
• Renal failure requiring dialysis
• Acute illness, active systemic infection, or sepsis
• Left ventricular ejection fraction (EF) < 40%
• Subjects will not be eligible for the study if any of the following criteria are met:
• Continuous AF lasting more than 12 months (long-standing persistent AF)
• Any carotid stenting or endarterectomy
• Documented left atrial thrombus on imaging
• Body mass index >40 kg/m2
• Left atrial diameter (anteroposterior) >50 mm for paroxysmal AF and >55mm for persistent AF
• Diagnosed atrial myxoma
• Hypertrophic cardiomyopathy
• Moderate to severe mitral valve stenosis
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
• Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results
• Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
• Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Life expectancy less than 12 months
• Vulnerable subject