CONVERGE Post-Approval Study (PAS)

Korábbi kezelés

• Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure;
• Previous cardiac surgery;
• Previous cerebrovascular accident (CVA), excluding fully resolved TIA;
• Patients who have had more than 2 prior left atrial catheter ablations for AF. NOTE: Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) and no other left atrial lesions;
• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment;

Más betegség

• Co-morbid medical conditions that limit one-year life expectancy;
• History of pericarditis;
• Patients who have active infection or sepsis
• Patients who are being treated for ventricular arrhythmias;
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Laborértékek

• Left ventricular ejection fraction < 35%;
• Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40);

Egyéb

• Pregnant or planning to become pregnant during study;
• Patients with esophageal ulcers strictures and varices;
• Patients who are contraindicated for anticoagulants such as heparin and coumadin;
• Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative);
• Patient has presence of thrombus in the left atrium determined by intraoperative TEE;
• Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 % stenosis;
• Planned Left Atrial Appendage Management (LAAM) with an endocardial implantable device during the course of the study;
• Presence of Barretts esophagitis

• Age ≥ 18 years and < 80 years at time of enrollment consent;
• Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality;
• Refractory or intolerant to at least one AAD (class I and/or III);
• Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (> 12 months of continuous AF);
• Life expectancy > 12 months; and
• Provides written informed consent.