New balloon shows promise in heart valve procedure

NCT ID NCT07304427

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a balloon catheter called Alwide Plus, used to widen the aortic valve before replacing it in people with severe aortic stenosis. 75 patients took part across multiple hospitals in China. The results showed the balloon was safe and effective for this pre-dilation step, helping the new valve be placed correctly.

What this could mean

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

Active substance: Alwide Plus balloon catheter
What this could lead to: If successful, this could confirm that the Alwide Plus balloon is a safe and effective tool for preparing the aortic valve before replacement, improving outcomes for patients with severe aortic stenosis.
What could go wrong: This is a small, single-arm study with no comparison group, so results may not apply to all patients. The balloon is only one part of a complex procedure, and success depends on many factors.

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 stenosis

As listed by the trial registrant

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

SEVERE AORTIC STENOSIS TRANSCATHETER AORTIC VALVE REPLACEMEN

Contacts and locations

Locations

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China
Guangdong Provincial People's Hospital

Guangzhou, China
Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China
Yan'an Hospital of Kunming City

Kunming, Yunnan, China

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