J-Valve Transfemoral Pivotal Study

Inclusion Criteria:

1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) IIor higher

2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory: A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4) B. OR, if indeterminate AR, by TTE, ANY ONE of the following: i. Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular enddiastolic volume index [LVEDVi]) >105 mL/m^2 for men or LVEDVi >96 mL/m^2 for women)iii. CMR-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left ventricular endsystolic volume index (LVESVi) ≥43mL/m^2; iv. Severe AR by TransesophagealEchocardiography (TEE) (grade 3 or 4)

3. High risk for surgery as judged by a multi-disciplinary heart team

4. Suitable anatomy to accommodate the insertion, delivery, and deployment of the studydevices (see anatomic exclusions below)

5. Written informed consent and agreement to comply with all required post-procedurefollow-up visits at investigational site.

Exclusion Criteria:

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 requiringchronic dialysis

9. Liver disease (cirrhosis of the liver [Child-Pugh Class B or C])

10. Blood dyscrasias as defined: leukopenia (WBC <3000 cells/mcL), thrombocytopenia (platelet count <50,000 cells/mcL), anemia (hemoglobin <9 g/dL), history of bleedingdiathesis coagulopathy, or hypercoagulable state (unless therapeutically stable)

11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin,clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, whichcannot be adequately premedicated

12. Left ventricular dysfunction with left ventricular ejection fraction (LVEF) <25% asmeasured by resting echocardiogram (or by CMR, when performed)*

13. Clinically significant untreated coronary artery disease requiring revascularizationor anticipated coronary revascularization procedure within 12-months post indexprocedure

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 arterydisease requiring intervention

17. Previous, or planned, other surgical or interventional procedures within 30 daysbefore, 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 ofsystemic systolic BP)

21. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroidsor requiring continuous home O2

22. Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptomsattributed to carotid or vertebrobasilar disease within 90 days prior to indexprocedure

23. Cardiogenic shock defined as systolic blood pressure <90 mmHg in addition to signsof tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamicsupport to maintain systolic blood pressure ≥90mmHg

24. Patient requires mechanical circulatory support within 30 days prior to indexprocedure

25. Estimated life expectancy of less than 24 months due to associated non-cardiacco-morbid conditions

26. Pregnancy or intent to become pregnant prior to completion of all protocol follow-uprequirements

27. Participation in another investigational study that has not reached its primaryendpoint

28. Considered to be part of a vulnerable population

• As assessed by Imaging Core Laboratory

Anatomic Exclusions:

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 Quadricuspidaortic valve anatomy*

6. Congenital univentricle or other condition that, in the opinion of the investigatorand/or consulting physician, may constitute an unwarranted surgical risk

7. Excessive aortic valve prolapse that would preclude proper seating of the implant inthe aortic annulus

8. Abdominal/thoracic aortic aneurysm ≥5.0 cm*

9. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath

10. Excessive tortuosity of delivery system pathway, defined as severe tortuosity ofmultiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, orLV-aortic root angle >80⁰

• As assessed by Imaging Core Laboratory