Evaluating the GEMINUS TAVI System for Aortic Stenosis

First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis

This study is testing a new heart valve system to see if it is safe and works well for people with severe aortic stenosis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: Valve Medical (industry)
• Locations: 2 sites (Petah Tikva and 1 other locations)
• Trial ID: NCT05909748 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with severe symptomatic aortic stenosis who are at intermediate surgical risk or are 75 years and older.

Not a fit: Patients with aortic stenosis who do not meet the specified anatomical and clinical criteria or those at low surgical risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with severe aortic stenosis, potentially improving their quality of life and survival rates.

How similar studies have performed: Other studies involving transcatheter aortic valve implantation have shown success, indicating that this approach is promising and not entirely novel.

Eligibility criteria

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 this trial is running

Petah Tikva and 1 other locations

• 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

Conditions: Aortic Valve Stenosis