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

NCT ID NCT05168826

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

Study facts

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

Participants

250 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Dec 2035

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 who will undergo TAVI with the Edwards SAPIEN 3 System.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment 2. All surgical risks as determined by the site Heart Team 3. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship 2. Considered to be part of a vulnerable population 3. Pre-existing mechanical or bioprosthetic aortic valve 4. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 5. Cannot tolerate an anticoagulation/antiplatelet regimen 6. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis 7. Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath 8. Participating in a drug or device study that has not reached its primary endpoint

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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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