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Less invasive heart valve fix could rival Open-Heart surgery for tough cases

NCT ID NCT06597188

ENROLLING_BY_INVITATION Disease control Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two ways to replace a narrowed heart valve in people with a bicuspid aortic valve (a common birth defect). One method is transcatheter aortic valve replacement (TAVR), a less invasive procedure using a tube inserted through a blood vessel. The other is traditional open-heart surgery. The trial will enroll 452 people up to age 75 with severe symptoms and moderate-to-low surgical risk. The main goal is to see if TAVR is as safe and effective as surgery after one year, looking at deaths, strokes, and heart-related hospital readmissions.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
VitaFlow Liberty transcatheter aortic valve
What this could lead to
If successful, this could show that a less invasive procedure works as well as open-heart surgery for people with bicuspid aortic valve stenosis, offering a quicker recovery option.
What could go wrong
This is a non-inferiority trial, meaning it aims to prove TAVR is not worse than surgery, not necessarily better. Results may not apply to older or higher-risk patients, and there are standard procedural risks like stroke or need for re-hospitalization.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

aortic valve disease 1 aortic valve disease 2 aortic valve stenosis Bicuspid Aortic Valve Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC STENOSIS BICUSPID AORTIC VALVE (BAV)

Contacts and locations

Locations

  • WEST CHINA Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

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