MedTrace Logo

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

NCT05909748 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-22

No results posted yet for this study

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

Interventions

DEVICE

GEMINUS Transcatheter Aortic Valve Implantation system

Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system

Sponsors & Collaborators

  • Valve Medical

    lead INDUSTRY

Principal Investigators

  • Ran Kornowski, Prof. · Rabin Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-21
Primary Completion
2026-05-31
Completion
2030-04-30

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05909748 on ClinicalTrials.gov