J-Valve TF Early Feasibility Study

Inclusion Criteria:

• Patient has symptomatic (NYHA FC ≥ IIs) severe (≥3+) native AR (per 2020 ACC/AHAGuideline for Management of Patients with Valvular Heart Disease) diagnosed byechocardiography. Patients will be assessed according to the current AmericanSociety of Echocardiography Guidelines for Non-invasive Evaluation of Native ValveRegurgitation. Transesophageal echocardiography (TEE) or cardiac MRI (CMR) will beused 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 heartdisease: STS-PROM score ≥8%, or if <8%, significant co-morbidities that are notcaptured by the STS-PROM score (e.g., ≥2 frailty indices, 1 to 2 major organ systemcompromise, the presence of certain procedure-specific factors that affect surgicalmortality), based on the consensus of a multi-disciplinary heart team;

• Patient has suitable anatomy for J-Valve implantation (see anatomic exclusionsbelow);

• Patient or the patient's legal representative has provided written informed consent;

• Patient or patient's legal representative agrees to comply with all requiredpost-procedure follow-up visits.

Exclusion Criteria:

• Patients that are at prohibitive surgical risk (predicted risk for mortality ormajor morbidity at 30 days >50% with SAVR);

• Mixed aortic valve disease, defined as coexistence of > moderate aortic valvestenosis with severe AR;

• Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin,ticlopidine, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity tocontrast media, which cannot be adequately premedicated;

• Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (plateletcount <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-uprequirements;

• Renal insufficiency (eGFR <25) and/or end stage renal disease requiring chronicdialysis;

• Pulmonary Hypertension (systolic pressure ≥2/3 of systemic);

• Severe Chronic Obstructive Pulmonary Disease (COPD) = requiring steroids orrequiring continuous home O2

• Severe mitral or severe tricuspid regurgitation or stenosis;

• Symptomatic carotid or vertebral artery disease or successful treatment of carotidstenosis within six weeks of treatment;

• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, ormechanical hemodynamic support;

• Recent (within 6 months of treatment) cerebrovascular accident (CVA) or transientischemic attack (TIA);

• Active gastrointestinal (GI) bleeding that would preclude anticoagulation;

• Untreated multivessel coronary artery disease with a Syntax score >22 and/orunprotected 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 (excludingcardiac) 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 investigatorand/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 ofmultiple vessels including iliofemoral, descending aorta, ascending aorta, aorticarch, and aortic angle >80⁰. In most cases, this exclusion will be identified andassigned following review by the multi-disciplinary Screening Committee.