Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart device study shows promise for stroke prevention in southeast asia

NCT ID NCT05687591

Disease control Sponsor: Sarawak Heart Centre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a device called Amplatzer Amulet that closes a small pouch in the heart (left atrial appendage) in people with atrial fibrillation. The goal was to see if it safely reduces stroke risk without long-term blood thinners. 104 adults at high stroke risk took part across multiple centers in Southeast Asia. Researchers checked for device problems, leaks, strokes, and bleeding over one year.

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

104 people

The number who actually took part.

Started

Oct 2022

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The subjects who are indicated for LAAO with the Amplatzer Amulet are eligible for the study. Subjects who had their occluder implanted, been recently implanted or intended to undergo the procedure may be considerd 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: * 18 year of age or older * Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation * At high risk of stroke or systemic embolism defined as CHA2DS2-VASc score of more than or equal to 3 * Deemed suitable for LAA occlusion by the treating physician, who might or might not be the investigator * Able to comply with the required medication regimen post-device implant * Able and willing to return for required follow-up visits and examinations Exclusion Criteria: * With active endocarditis or other infections producing bacteremia * Where placement of the device would interfere with any intracardiac or intravascular structures * Reversible cause of AF (i.e. secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) * Hypersensitivity to any portion of the device material or individual components of the Amulet LAA closure device * Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requireemnts, or impact the scientific soundness of the clinical trial results.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Atrial fibrillation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Atrial fibrillation

Contacts and locations

Locations

  • Sarawak Heart Centre

    Kuching, Sarawak, 94300, Malaysia

More trials for these conditions

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