Evaluating the GEMINUS TAVI System for Aortic Stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the feasibility and safety of the GEMINUS Transcatheter Aortic Valve Implantation system in patients suffering from severe symptomatic aortic stenosis. It is a prospective, open-label, multicenter, single-arm study that will follow participants for up to five years post-implantation. The study will include regular clinical evaluations at specified intervals to monitor patient outcomes and device performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Patient understands the implications of participating in the study and provides informed consent
3. Patient is willing to comply with specified follow-up evaluation
4. 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 low flow low gradient AS or paradoxical low flow severe AS must meet ACC/AHA guidelines (table 13 stages of AS in the guideline)
5. Cardiac Symptoms: ≥ NYHA Class II
6. Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old.
7. Aortic annulus diameter ≥22 mm and \< 29 mm, assessed by CT TAVI
8. Anatomically suitable for implantation of the GEMINUS device
9. Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimal diameter \> 4mm), tortuosity, and calcification to accommodate the 12Fr catheter system.
10. 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.

Exclusion Criteria:

1. Patient not suitable for surgical bailout
2. Congenital uni/bi/quadricuspid valve, or noncalcified aortic valve.
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation ≥3+).
4. Active or recent (within 6 months) endocarditis.
5. Active systemic infections.
6. Recent MI (≤ 1 month).
7. Any therapeutic invasive cardiac procedure (except BAV) performed within 30 days of the index procedure.
8. Prosthetic heart valve in any position.
9. Severe (\> 3+) mitral, tricuspid or pulmonic regurgitation.
10. 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.
11. Untreated clinically significant coronary artery disease requiring revascularization.
12. Hemodynamic instability requiring inotropic support or mechanical support devices.
13. Hypertrophic cardiomyopathy with or without obstruction (HCM).
14. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20%.
15. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
16. Active peptic ulcer or upper GI bleeding within the prior 3 months.
17. Known hypersensitivity or contraindication to heparin, inability to tolerate antiplatelet therapy or sensitivity to contrast media (which cannot be adequately premedicated).
18. Recent (\<6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
19. Renal insufficiency (eGFR\<30 mL/min) and/or end stage renal disease requiring chronic dialysis.
20. Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter \> 5cm), marked tortuosity, or severe aortic arch atheroma.
21. Life expectancy \< 12 months due to non-cardiac co-morbid conditions.
22. Currently participating in an investigational drug or another device study that has not reached its primary endpoint

Where it's running

• Rabin Medical Center
  Petah Tikva, Israel Recruiting
• Tel Aviv Sourasly Medical Center
  Tel Aviv, Israel Not yet recruiting

Study contacts

• Principal investigator: Ran Kornowski, Prof. — Rabin Medical Center
• Study coordinator: Brenda Koltun Reuven
• Email: brendak@medinol.com
• Phone: 972-542666688

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.