FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis (NCT05909748) | Clinical Trial Compass
RecruitingNot Applicable
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
Israel30 participantsStarted 2023-05-21
Plain-language summary
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
Who can participate
Age range18 Years – 120 Years
SexALL
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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
✓. 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
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.