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Heart valve study shows strong safety in chinese patients

NCT ID NCT05330468

Disease control Sponsor: Abbott Medical Devices 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how safe and effective Abbott's Regent mechanical heart valve is for Chinese patients needing a new aortic valve. Researchers followed 200 adults who received the valve to track valve-related deaths and the need for repeat surgery. The goal was to confirm the valve works well in this population.

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

200 people

The number who actually took part.

Started

Mar 2022

Finished

Oct 2024

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

This clinical investigation will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.

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. Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic valve per Regent's IFU. 2. Subject will be \>18 years of age at time of being consented. 3. Subject, provides written informed consent prior to any clinical investigation-specific procedure. Exclusion Criteria: 1. Subject is unable to tolerate anticoagulation therapy. 2. Subject has active endocarditis. 3. Subject is currently participating in another clinical investigation which may interfere with the effectiveness of anticoagulation therapy. 4. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Women of child-bearing potential must have a documented negative pregnancy test within one week prior to enrollment. 5. Subject has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results. 6. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent. 7. Subject's life expectancy is less than 1 year in the opinion of the Investigator.

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disorder heart valve disorder

As listed by the trial registrant

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

Aortic valve disease Valvular heart disease

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, China

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, China

  • The People's Hospital of Gaozhou

    Gaozhou, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, China

  • Wuhan Union Hospital of China

    Wuhan, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.