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New treatment option for Aortic Valve Stenosis
Official title FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis
ClinicalTrials.gov ID: NCT05909748
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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)\ \...
- Cardiac Symptoms: ≥ NYHA Class II
You likely can't join if
- 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.
- Active systemic infections.
- Recent MI (≤ 1 month).
See the full eligibility 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 \ May be larger with mixed AS/AR \ \ For...
- 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.
- 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.
- Active systemic infections.
- Recent MI (≤ 1 month).
- Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days of the index procedure.
- Prosthetic heart valve in any position.
- Severe (\> 3+) mitral, tricuspid or pulmonic regurgitation.
- Blood dyscrasias as defined: leukopenia (WBC\<3000/mm3), acute anemia (Hb \<8mg%), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Hemodynamic instability requiring inotropic support or mechanical support devices.
- Hypertrophic cardiomyopathy with or without obstruction (HCM).
- Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20%.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active peptic ulcer or upper GI bleeding within the prior 3 months.
- Known hypersensitivity or contraindication to heparin, inability to tolerate antiplatelet therapy or sensitivity to contrast media (which cannot be adequately premedicated).
- Recent (\<6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Renal insufficiency (eGFR\<30 mL/min) and/or end stage renal disease requiring chronic dialysis.
- Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter \> 5cm), marked tortuosity, or severe aortic arch atheroma.
- Life expectancy \< 12 months due to non-cardiac co-morbid conditions.
- Currently participating in an investigational drug or another device study that has not reached its primary endpoint
The study team makes the final eligibility decision.
Where it's taking place
- Petah Tikva, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Petah Tikva, Israel; Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.