FIH Study of the GEMINUS TAVI System in Patients with Severe Symptomatic Aortic Stenosis

Inclusion Criteria:

1. Age ≥ 18 years

2. Patient understands the implications of participating in the study and providesinformed consent

3. Patient is willing to comply with specified follow-up evaluation

4. Severe aortic stenosis as per ACC/AHA 2020 guidelines (e.g. AVA ≤ 1.0 cm2 (or AVAindex ≤ 0.6cm2/m2)* AND PV ≥ 4 m/sec or mean gradient ≥ 40 mmHg)** as determined byTTE/CT-TAVI

*May be larger with mixed AS/AR

**For low flow low gradient AS or paradoxical low flow severe AS must meet ACC/AHAguidelines (table 13 stages of AS in the guideline)

5. Cardiac Symptoms: ≥ NYHA Class II

6. Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old.

7. Aortic annulus diameter ≥22 mm and < 29 mm, assessed by CT TAVI

8. Anatomically suitable for implantation of the GEMINUS device

9. Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimaldiameter > 4mm), tortuosity, and calcification to accommodate the 12Fr cathetersystem.

10. Patients assessed by the heart team to be at high risk for access site relatedbleeding/vascular complications due to the caliber/ calcification/ atherosclerosisof the iliofemoral vessels.

Exclusion Criteria:

1. Patient not suitable for surgical bailout

2. Congenital uni/bi/quadricuspid valve, or noncalcified aortic valve.

3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation withpredominant aortic regurgitation ≥3+).

4. Active or recent (within 6 months) endocarditis.

5. Active systemic infections.

6. Recent MI (≤ 1 month).

7. Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days ofthe index procedure.

8. Prosthetic heart valve in any position.

9. Severe (> 3+) mitral, tricuspid or pulmonic regurgitation.

10. Blood dyscrasias as defined: leukopenia (WBC<3000/mm3), acute anemia (Hb <8mg%),thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesisor coagulopathy.

11. Untreated clinically significant coronary artery disease requiringrevascularization.

12. Hemodynamic instability requiring inotropic support or mechanical support devices.

13. Hypertrophic cardiomyopathy with or without obstruction (HCM).

14. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%.

15. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

16. Active peptic ulcer or upper GI bleeding within the prior 3 months.

17. Known hypersensitivity or contraindication to heparin, inability to tolerateantiplatelet therapy or sensitivity to contrast media (which cannot be adequatelypremedicated).

18. Recent (<6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).

19. Renal insufficiency (eGFR<30 mL/min) and/or end stage renal disease requiringchronic dialysis.

20. Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumendiameter > 5cm), marked tortuosity, or severe aortic arch atheroma.

21. Life expectancy < 12 months due to non-cardiac co-morbid conditions.

22. Currently participating in an investigational drug or another device study that hasnot reached its primary endpoint