Can a tiny valve replace Open-Heart surgery for the long haul?

NCT ID NCT05168826

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

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study follows 250 people with severe aortic stenosis who receive the SAPIEN 3 transcatheter heart valve as part of their standard care. The goal is to see how safe and effective the valve is over the long term in everyday clinical practice. Researchers will track how many patients die from any cause after the procedure. The study includes patients of all surgical risk levels, as determined by their heart team.

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 confirm that the SAPIEN 3 valve is a safe and effective long-term option for people with severe aortic stenosis who cannot have open-heart surgery.
What could go wrong: This is an observational registry, not a randomized trial, so it cannot prove the valve is better than other treatments. Long-term risks may include valve deterioration, blood clots, or the need for repeat procedures.

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 cardiovascular disorder heart disorder

As listed by the trial registrant

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

AORTIC STENOSIS, SEVERE

Contacts and locations

Locations

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China
First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China
Henan Provincial Chest Hospital

Zhengzhou, Henan, 450000, China
Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China
People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830000, China
Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China
Shanghai General Hospital

Shanghai, Shangahi, 200000, China
The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710000, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China
The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China
Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361004, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

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