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New heart valve study tracks safety in chinese patients over time

NCT ID NCT05404880

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 255 Chinese patients who received the INSPIRIS RESILIA aortic valve to see how safe and well it works over several years. Researchers track problems like valve failure, blood clots, bleeding, and the need for another surgery. The goal is to confirm the valve's long-term performance in real-world use.

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

Study facts

What this study's own registry entry says, in plain language.

Participants

255 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects requiring an elective replacement of their native or prosthetic aortic valve who have agreed to participate in the study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject is 18 years or older 2. Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU 3. Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement 4. Provide signed informed consent prior to the study participation Exclusion Criteria: 1. Valve implantation is contraindicated per the IFU 2. Requires planned multiple valve replacement/ repair 3. Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery 4. Estimated Life expectancy\< 12 months 5. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial

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Conditions

The condition(s) this trial relates to.

aortic valve disorder

As listed by the trial registrant

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

Aortic valve replacement

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029, China

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, 451460, China

  • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

    Shenzhen, Guangdong, 518038, China

  • Fuwai Hospital, CAMS & PUMC

    Beijing, Beijing Municipality, 100037, China

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming, Yunnan, 650102, China

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan, 450008, China

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210012, China

  • Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui, 230002, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710065, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, Fujian, 361008, China

More trials for these conditions

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