FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorValve Medical
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GEMINUS Transcatheter Aortic Valve Implantation system
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov