NCT05909748

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Valve Medical · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	GEMINUS Transcatheter Aortic Valve Implantation system	Implantation of the GEMINUS Transcatheter Aortic Valve Implantation system

Timeline

• Start date: 2023-05-21
• Primary completion: 2026-05-01
• Completion: 2030-04-01
• First posted: 2023-06-18
• Last updated: 2025-09-22

Locations

2 sites across 1 country: Israel