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

NCT05909748 | Recruiting

• 1 other identifier: GEMINUS-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Technical success (at exit from procedure room)

  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

  immediately after procedure

Secondary Outcomes (19)

• Device success composite endpoint

  30 days

• Early safety composite endpoint (VARC 3)

  30 days

• Early safety composite endpoint (Modified VARC)

  30 days

• Clinical efficacy composite endpoint

  1, 2, 3, 4, 5 years

• All-cause mortality

  30 days, 6 months, 1, 2, 3, 4, 5 years

Study Arms (1)

GEMINUS Transcatheter Aortic Valve Implantation system

EXPERIMENTAL

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

Interventions

GEMINUS Transcatheter Aortic Valve Implantation system DEVICE

Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system

Also known as: GEMINUS TAVI system

GEMINUS Transcatheter Aortic Valve Implantation system

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)\*\* 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)
• 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.

You may not qualify 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).
• 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.

Sponsors & Collaborators

• Valve Medical: lead

Study Sites (2)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Tel Aviv Sourasly Medical Center

Tel Aviv, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Ran Kornowski, Prof.

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Koltun Reuven

CONTACT

972-542666688; brendak@medinol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 18, 2023
• Study Start: May 21, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): April 1, 2030
• Last Updated: September 22, 2025

Record last verified: 2025-03

Locations

IL (2)