J-Valve TF Early Feasibility Study (JVTF EFS)

Inclusion Criteria: Patient has symptomatic (NYHA FC ≥ IIs) severe (≥3+) native AR (per 2020 ACC/AHA Guideline for Management of Patients with Valvular Heart Disease) diagnosed by echocardiography. Patients will be assessed according to the current American Society of Echocardiography Guidelines for Non-invasive Evaluation of Native Valve Regurgitation. Transesophageal echocardiography (TEE) or cardiac MRI (CMR) will be used in case of indeterminant AR; Patient is judged by a multi-disciplinary heart team to be at high risk for surgery, based on the ACC/AHA guidelines for management of patients with valvular heart disease: STS-PROM score ≥8%, or if <8%, significant co-morbidities that are not captured by the STS-PROM score (e.g., ≥2 frailty indices, 1 to 2 major organ system compromise, the presence of certain procedure-specific factors that affect surgical mortality), based on the consensus of a multi-disciplinary heart team; Patient has suitable anatomy for J-Valve implantation; Patient or the patient's legal representative has provided written informed consent; Patient or patient's legal representative agrees to comply with all required post-procedure follow-up visits. Exclusion Criteria: Patients that are at prohibitive surgical risk (predicted risk for mortality or major morbidity at 30 days >50% with SAVR); Mixed aortic valve disease, defined as coexistence of > moderate aortic valve stenosis with severe AR; Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity to contrast media, which cannot be adequately premedicated; Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy; Active infection, including infective endocarditis; Liver failure (Child-C); Reduced left ventricular function with left ventricular ejection fraction (LVEF) <25% as measured by resting echocardiogram; Uncontrolled atrial fibrillation (e.g., resting heart rate >120 bpm); Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements; Renal insufficiency (eGFR <25) and/or end stage renal disease requiring chronic dialysis; Pulmonary Hypertension (systolic pressure ≥2/3 of systemic); Severe Chronic Obstructive Pulmonary Disease (COPD) = requiring steroids or requiring continuous home O2 Severe mitral or severe tricuspid regurgitation or stenosis; Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of treatment; Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; Recent (within 6 months of treatment) cerebrovascular accident (CVA) or transient ischemic attack (TIA); Active gastrointestinal (GI) bleeding that would preclude anticoagulation; Untreated multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery; Evidence of acute myocardial infarction within 1 month of intended procedure; Estimated life expectancy of less than 24 months due to associated (excluding cardiac) co-morbid conditions; Left Ventricular Assist Device (LVAD) dependent; Participating in another study that may influence the outcome of this study; Need for emergency surgery for any reason; Previous aortic bioprosthesis or mechanical implant. Anatomic Exclusion Criteria: Ascending Aortic diameter >5 cm; Aortic Annulus Perimeter <57 mm or >104 mm; Access vessel minimum diameter <5.5 mm; LVEDD >75 mm; Bicuspid aortic valve disease; Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk.