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

Inclusion criteria

• Age ≥ 18 years
• Patient understands the implications of participating in the study and provides informed consent
• Patient is willing to comply with specified follow-up evaluation
• Severe aortic stenosis as per ACC/AHA 2020 guidelines (e.g. AVA ≤ 1.0 cm2 (or AVA index ≤ 0.6cm2/m2)* AND PV ≥ 4 m/sec or mean gradient ≥ 40 mmHg)** as determined by TTE/CT-TAVI

*May be larger with mixed AS/AR

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

• Cardiac Symptoms: ≥ NYHA Class II
• Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old.
• Aortic annulus diameter ≥22 mm and < 29 mm, assessed by CT TAVI
• Anatomically suitable for implantation of the GEMINUS device
• Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimal diameter > 4mm), tortuosity, and calcification to accommodate the 12Fr catheter system.
• Patients assessed by the heart team to be at high risk for access site related bleeding/vascular complications due to the caliber/ calcification/ atherosclerosis of the iliofemoral vessels.

Exclusion criteria

• Patient not suitable for surgical bailout
• Congenital uni/bi/quadricuspid valve, or noncalcified aortic valve.
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation ≥3+).
• Active or recent (within 6 months) endocarditis.
• Active systemic infections.
• Recent MI (≤ 1 month).
• Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days of the index procedure.
• Prosthetic heart valve in any position.
• Severe (> 3+) mitral, tricuspid or pulmonic regurgitation.
• Blood dyscrasias as defined: leukopenia (WBC<3000/mm3), acute anemia (Hb <8mg%), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Hemodynamic instability requiring inotropic support or mechanical support devices.
• Hypertrophic cardiomyopathy with or without obstruction (HCM).
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active peptic ulcer or upper GI bleeding within the prior 3 months.
• Known hypersensitivity or contraindication to heparin, inability to tolerate antiplatelet therapy or sensitivity to contrast media (which cannot be adequately premedicated).
• Recent (<6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Renal insufficiency (eGFR<30 mL/min) and/or end stage renal disease requiring chronic dialysis.
• Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter > 5cm), marked tortuosity, or severe aortic arch atheroma.
• Life expectancy < 12 months due to non-cardiac co-morbid conditions.
• Currently participating in an investigational drug or another device study that has not reached its primary endpoint