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Stroke prevention device tested in chinese heart patients

NCT ID NCT06189365

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tested a device called the Amplatzer Amulet, which is implanted to close a part of the heart and reduce stroke risk in people with non-valvular atrial fibrillation who cannot take blood thinners. The study enrolled 50 participants in China and tracked safety and effectiveness for up to 2 years. However, the study was terminated early, so the full results are not available.

What this could mean

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

Active substance
Amplatzer Amulet LAA occluder device
What this could lead to
If successful, this device could offer a safe alternative to long-term blood thinners for preventing stroke in people with atrial fibrillation.
What could go wrong
The study was terminated early with only 50 participants, so results are limited. Risks include serious complications like stroke, device-related infections, or device movement.

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

50 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

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 subjects of all genders from the Chinese nationality general population ≥18 years old. 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. Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events 2. Meets the current device indications and per physician discretion for Amulet implant 3. Able to provide written Informed Consent prior to any study related procedures 4. 18 years of age or older at the time of enrolment Exclusion Criteria: 1. With the presence of intracardiac thrombus 2. With active endocarditis or other infections producing bacteremia 3. Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score \< 3) 4. Where placement of the device would interfere with any intracardiac or intravascular structures 5. Has a life expectancy of less than 2 years due to any condition 6. Currently participating or planning on participating during the follow up period of this study in a clinical study that includes an active treatment arm or a concurrent clinical study which may confound the results of this trial

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Non valvular atrial fibrillation

Contacts and locations

Locations

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013, China

  • University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518009, China

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022, China

  • Xiangya Hospital Zhuzhou Central South University

    Zhuzhou, Hunan, 412007, China

  • Xianyang Hospital Of Yan'an University

    Xianyang, Shaanxi, China

More trials for these conditions

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