J-Valve TF Early Feasibility Study

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 (see anatomic exclusions below); * 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; * PCI within 30 days 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. * Abdominal aortic aneurysm ≥ 4.0 cm; * Aorto-iliac disease requiring intervention to facilitate delivery of access sheath; * Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, descending aorta, ascending aorta, aortic arch, and aortic angle \>80⁰. In most cases, this exclusion will be identified and assigned following review by the multi-disciplinary Screening Committee.