Actively Recruiting
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
Led by Valve Medical · Updated on 2025-09-22
30
Participants Needed
2
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient understands the study and provides informed consent
- Willing to comply with follow-up evaluations
- Severe aortic stenosis as defined by ACC/AHA 2020 guidelines
- Cardiac symptoms at NYHA Class II or higher
- Intermediate surgical risk or age 75 years or older
- Aortic annulus diameter between 22 mm and less than 29 mm
- Anatomically suitable for GEMINUS device implantation
- Peripheral vessels suitable for 12Fr catheter system (diameter > 4mm)
- Assessed high risk for access site bleeding or vascular complications due to vessel condition
You will not qualify if you...
- Not suitable for surgical bailout
- Congenital uni/bi/quadricuspid valve or noncalcified aortic valve
- Predominant aortic regurgitation (grade 3+ or higher) with mixed valve disease
- Active or recent endocarditis (within 6 months)
- Active systemic infections
- Recent myocardial infarction (within 1 month)
- Invasive cardiac procedures (except BAV) within 30 days
- Prosthetic heart valve in any position
- Severe mitral, tricuspid, or pulmonic regurgitation (grade > 3+)
- Blood disorders including leukopenia, acute anemia, thrombocytopenia, bleeding disorders
- Untreated significant coronary artery disease needing revascularization
- Hemodynamic instability requiring inotropic or mechanical support
- Hypertrophic cardiomyopathy with or without obstruction
- Severe ventricular dysfunction with LVEF less than 20%
- Intracardiac mass, thrombus, or vegetation seen on echocardiogram
- Active peptic ulcer or recent upper gastrointestinal bleeding (within 3 months)
- Hypersensitivity or contraindication to heparin, antiplatelet therapy, or contrast media
- Recent cerebrovascular accident or transient ischemic attack (within 6 months)
- Renal insufficiency (eGFR less than 30 mL/min) or end stage renal disease on dialysis
- Severe aortic disease such as large aneurysms, marked tortuosity, or severe atheroma
- Life expectancy less than 12 months due to non-cardiac conditions
- Currently in another investigational drug or device study without primary endpoint reached
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
2
Tel Aviv Sourasly Medical Center
Tel Aviv, Israel
Not Yet Recruiting
Research Team
B
Brenda Koltun Reuven
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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