First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis
The main objective of this study is to evaluate the feasibility and safety of the GEMINUS system in patients with severe symptomatic aortic stenosis. This is a prospective, open label, multicentre, single arm, first in human clinical study. Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation
• 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.