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Venus-Vitae Pivotal Study Smart-Align Study - Trial NCT05991271

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.

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Trial Details
ClinicalTrials.gov • NCT05991271
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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

Study Focus

Aortic Valve Stenosis

Venus-Vitae Transcatheter Heart Valve System

Interventional

device

Sponsor & Location

Venus MedTech (HangZhou) Inc.

Timeline & Enrollment

N/A

Oct 31, 2023

Jun 30, 2029

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

Data Source

ClinicalTrials.gov

NCT05991271

Device Trial