Status: Recruiting
FIH Study of the GEMINUS TAVI 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
Participants needed: 30
Trial details
Age: 18-120Biological sex: AllType: InterventionalSponsor: Valve MedicalUpdated: Aug 21, 2026Locations: 2
Eligibility criteria
Age ≥ 18 years [+9]
Patient not suitable for surgical bailout [+21]