FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis

NCT ID: NCT05909748

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-21
• Study Completion Date: 2030-04-30

Brief Summary

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

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GEMINUS Transcatheter Aortic Valve Implantation system

Clinical follow up for all patients will be performed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implantation

Group Type: EXPERIMENTAL

GEMINUS Transcatheter Aortic Valve Implantation system

Intervention Type: DEVICE

Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system

Interventions

GEMINUS Transcatheter Aortic Valve Implantation system

Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system

Intervention Type: DEVICE

Other Intervention Names

GEMINUS TAVI system

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valve Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ran Kornowski, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Tel Aviv Sourasly Medical Center

Tel Aviv, , Israel

Site Status: NOT_YET_RECRUITING

Countries

Israel

Central Contacts

Brenda Koltun Reuven

Role: CONTACT

brendak@medinol.com

972-542666688

Facility Contacts

Ran Kornowski, Prof.

Role: primary

Maayan Konigstein, Prof.

Role: primary

Other Identifiers

GEMINUS-001

Identifier Type: -

Identifier Source: org_study_id