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FIH Study of the GEMINUS TAVI System in Patients With Severe Symptomatic Aortic Stenosis - Trial NCT05909748

Access comprehensive clinical trial information for NCT05909748 through Pure Global AI's free database. This phase not specified trial is sponsored by Valve Medical and is currently Recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.gov โ€ข NCT05909748
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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

Study Focus

Aortic Valve Stenosis

GEMINUS Transcatheter Aortic Valve Implantation system

Interventional

device

Sponsor & Location

Valve Medical

Petah tikva,Tel Aviv, Israel

Timeline & Enrollment

N/A

May 21, 2023

Apr 01, 2030

30 participants

Primary Outcome

Technical success (at exit from procedure room)

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

ICD-10 Classifications

Aortic (valve) stenosis
Aortic (valve) stenosis with insufficiency
Congenital stenosis of aortic valve
Stenosis of aorta
Rheumatic aortic stenosis

Data Source

ClinicalTrials.gov

NCT05909748

Device Trial