New heart valve offers hope for High-Risk chinese patients

NCT ID NCT03466918

Completed Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

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

Summary

This study tested a new heart valve, the SAPIEN 3, in 58 Chinese patients with severe aortic stenosis who were at high risk for traditional open-heart surgery. The valve was implanted using a thin tube through a blood vessel, avoiding the need for open surgery. The main goal was to see how many patients survived and how safe the procedure was.

What this could mean

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

Active substance: SAPIEN 3 transcatheter heart valve
What this could lead to: If successful, this could provide a less invasive treatment option for Chinese patients with severe aortic stenosis who are too high-risk for open-heart surgery.
What could go wrong: This was a small, single-arm study (58 participants) with no comparison group, so results may not apply broadly. Risks include stroke, bleeding, or valve-related complications.

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 insufficiency aortic valve stenosis

As listed by the trial registrant

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

AORTIC REGURGITATION AORTIC STENOSIS SYMPTOMATIC AORTIC STENOSIS

Contacts and locations

Locations

Fuwai Hospital, CAMS&PUMC

Beijing, China
The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China
WestChina Hospital, Sichuan University

Chengdu, China
Zhongshan Hospital Fudan University

Shanghai, China

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