Pure Global
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
Valve Medical·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Aortic Valve Stenosis
Drug/Device/Intervention
GEMINUS Transcatheter Aortic Valve Implantation system
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Valve Medical
Location
Petah tikva,Tel Aviv, Israel
Timeline & enrollment
Phase
N/A
Start date
May 21, 2023
End date
Apr 01, 2030
Enrollment
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) stenosisAortic (valve) stenosis with insufficiencyCongenital stenosis of aortic valveStenosis of aortaRheumatic aortic stenosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05909748
Type
Device Trial
About this record

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.