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

• Sponsor: Valve Medical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05909748
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 82.4
• Patients Per Site: 15
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: GEMINUS Transcatheter Aortic Valve Implantation system	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: First in Human Study of the GEMINUS Transcatheter Aortic Valve Implantation System in Patients With Severe Symptomatic Aortic Stenosis
• Actual Study Start Date: May 21, 2023
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: Apr 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: GEMINUS Transcatheter Aortic Valve Implantation system; Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system; Other Names: GEMINUS TAVI system

Outcome Measures

Primary Outcome Measures

1. Technical success (at exit from procedure room) [immediately after procedure]

   Technical success (at exit from procedure room) composite endpoint: Freedom from mortality, Successful access, delivery of the device, and retrieval of the delivery System, Correct positioning of a single prosthetic heart valve into the proper anatomical location, Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

Secondary Outcome Measures

1. Device success composite endpoint [30 days]

   Device success composite endpoint: Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)

2. Early safety composite endpoint (VARC 3) [30 days]

   Early safety composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from ≥ VARC-3 type 2 bleeding; Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device

3. Early safety composite endpoint (Modified VARC) [30 days]

   Early safety composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from ≥ Modified VARC type 3 bleeding; Freedom from major vascular, access-related, or cardiac structural complication; Freedom from acute kidney injury stage 3 or 4; Freedom from moderate or severe aortic regurgitation; Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; Freedom from surgery or intervention related to the device

4. Clinical efficacy composite endpoint [1, 2, 3, 4, 5 years]

   Clinical efficacy composite endpoint: Freedom from all-cause mortality; Freedom from all stroke; Freedom from hospitalization for procedure- or valve-related causes; Freedom from KCCQ Overall Summary Score <45 or decline from baseline of >10 point (i.e. Unfavourable Outcome)

5. All-cause mortality [30 days, 6 months, 1, 2, 3, 4, 5 years]

   All-cause mortality

6. Disabling stroke [6 months, 2, 3, 4, 5 years]

   Disabling stroke

7. Any stroke [30 days, 6 months, 1, 2, 3, 4, 5 years]

   Any stroke

8. Peri-procedural MI (per ARC-2) [within 2 days after procedure]

   Peri-procedural MI (per ARC-2).

9. Repeat hospitalization for procedure or valve related cause [30 days, 6 months, 1, 2, 3, 4, 5 years]

   Repeat hospitalization for procedure or valve related cause

10. Repeat aortic valve intervention [30 days, 6 months, 1, 2, 3, 4, 5 years]

    Repeat aortic valve intervention

11. AKI (Stage 3 or 4) [30 days]

    AKI (Stage 3 or 4)

12. Bleeding ≥ VARC-3 type 2 [30 days, 6 months, 1, 2, 3, 4, 5 years]

    Bleeding ≥ VARC-3 type 2

13. Bleeding ≥ Modified VARC type 3 [30 days, 6 months, 1, 2, 3, 4, 5 years]

    Bleeding ≥ Modified VARC type 3

14. KCCQ [6 months, 1 year]

    KCCQ

15. Hemodynamic valve performance: Mean pressure gradient [pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years]

    Hemodynamic valve performance: Mean pressure gradient

16. Hemodynamic valve performance: peak velocity [pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years]

    Hemodynamic valve performance: peak velocity

17. Hemodynamic valve performance: aortic valve area [pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years]

    Hemodynamic valve performance: aortic valve area

18. Hemodynamic valve performance: aortic regurgitation [pre-discharge, 30 days, 6 months, 1, 2, 3, 4, 5 years]

    Hemodynamic valve performance: aortic regurgitation

19. Freedom from new permanent pacemaker due to procedure-related conduction abnormalities [30 days]

    Freedom from new permanent pacemaker due to procedure-related conduction abnormalities

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. Cardiac Symptoms: ≥ NYHA Class II

2. Patient ≥ intermediate surgical risk as assessed by the heart team or ≥75 years old.

3. Aortic annulus diameter ≥22 mm and < 29 mm, assessed by CT TAVI

4. Anatomically suitable for implantation of the GEMINUS device

5. Peripheral vessels (common femoral and iliac arteries) of acceptable size (minimal diameter > 4mm), tortuosity, and calcification to accommodate the 12Fr catheter system.

6. 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.

1. Life expectancy < 12 months due to non-cardiac co-morbid conditions.

2. Currently participating in an investigational drug or another device study that has not reached its primary endpoint

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petah tikva		Israel
2	Tel Aviv Sourasly Medical Center	Tel Aviv		Israel

Sponsors and Collaborators

• Valve Medical

Investigators

• Principal Investigator: Ran Kornowski, Prof., Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Valve Medical
• ClinicalTrials.gov Identifier: NCT05909748
• Other Study ID Numbers: GEMINUS-001
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Jun 18, 2023