J-Valve Transfemoral Pivotal Study

Eligibility Criteria

• 1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher
• 2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory:
• 3. Patient is judged by a multi-disciplinary heart team to be at high risk for surgery
• 4. Patient has suitable anatomy to accommodate the insertion, delivery, and deployment of the study valve system
• 5. Patient or the patient's legal representative has provided written informed consent and agrees to comply with all required post-procedure follow-up visits at investigational site.
• 1. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• 2. Aortic valve stenosis \> moderate
• 3. Severe mitral valve or tricuspid valve regurgitation
• 4. Severe mitral valve or tricuspid valve stenosis
• 5. Active infection, including infective endocarditis
• 6. Cardiac imaging evidence of cardiac mass, thrombus or vegetation
• 7. Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
• 8. Renal insufficiency (eGFR \<30 mL/min/1.73m\^2) or end stage renal disease requiring chronic dialysis
• 9. Liver disease including cirrhosis (Childs-Pugh Class B or C)
• 10. Blood dyscrasias as defined: leukopenia (WBC \<3000 mm\^3), thrombocytopenia (platelet count \<50,000 cells/mm\^3), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis or coagulopathy
• 11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity to contrast media, which cannot be adequately premedicated
• 12. Left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram (or by CMR, when performed)
• 13. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure
• 14. Acute myocardial infarction within 30 days prior to index procedure
• 15. PCI within 30 days prior to index procedure
• 16. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
• 17. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
• 18. Uncontrolled atrial fibrillation
• 19. Severe right ventricular (RV) dysfunction
• 20. Pulmonary hypertension (systolic PA pressure \>70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)
• 21. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2
• 22. Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 3 months prior to index procedure
• 23. Cardiogenic shock defined as systolic blood pressure \<90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg
• 24. Patient requires mechanical circulatory support within 30 days prior to index procedure
• 25. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
• 26. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
• 27. Participation in another investigational study that has not reached its primary endpoint
• 28. Subject considered to be part of a vulnerable population
• 1. Ascending Aortic diameter \>5 cm
• 2. Aortic Annulus Perimeter \<57 mm or \>104 mm
• 3. Inappropriate anatomy for femoral introduction and delivery of the study system
• 4. Left ventricular end-diastolic diameter (LVEDD) \>75 mm
• 5. Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy
• 6. Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
• 7. Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus
• 8. Abdominal/thoracic aortic aneurysm ≥4.0 cm
• 9. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
• 10. Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, or LV-aortic root angle \>80⁰