RecruitingNot ApplicableNCT05909748

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

Sponsor

Valve Medical

Enrollment

30 participants

Start Date

May 21, 2023

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Stenosis

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

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called GEMINUS Transcatheter Aortic Valve Implantation system for people with aortic valve stenosis. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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