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NCT05991271

Venus-Vitae Pivotal Study Smart-Align Study

Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System
Venus MedTech (HangZhou) Inc.·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Aortic Valve Stenosis
Drug/Device/Intervention
Venus-Vitae Transcatheter Heart Valve System
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Venus MedTech (HangZhou) Inc.
Timeline & enrollment
Phase
N/A
Start date
Oct 31, 2023
End date
Jun 30, 2029
Enrollment
150 participants
Primary outcome

The rate of deaths at the one-year follow-up visit post procedure,Acceptable Hemodynamic Performance at 30 days

Summary

The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae
 Transcatheter Heart Valve System in patients with severe aortic stenosis.

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
NCT05991271
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05991271 through Pure Global AI's free database. This phase not specified trial is sponsored by Venus MedTech (HangZhou) Inc. and is currently Not yet recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 150 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.