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New study tracks amulet Device's Real-World success in preventing strokes

NCT ID NCT05997446

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observes over 600 people with atrial fibrillation who received the Amulet device to close a part of the heart called the left atrial appendage. The goal is to see how well the device prevents strokes and bleeding in everyday medical practice. Participants are followed for 24 months to track safety and effectiveness.

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

610 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Jun 2027

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

Patients with non-valvular atrial fibrillation who are at increased risk for ischemic stroke or systemic embolism.

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: * Intended for LAAO with the Amulet device * At least 18 years of age * Willing and capable of providing informed consent and participating in all testing associated with this clinical study Exclusion Criteria: * Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhage hemorrhagic disease stroke disorder prevention target

As listed by the trial registrant

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

Atrial fibrillation Bleeding Stroke

Contacts and locations

Locations

  • Arizona Arrhythmia Research

    Phoenix, Arizona, 85016, United States

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • Baylor All Saints Medical Center at Fort Worth

    Fort Worth, Texas, 76104, United States

  • Bryan Heart

    Lincoln, Nebraska, 68506, United States

  • CHI Health Creighton University Medical Center-Bergan Mercy

    Omaha, Nebraska, 68124, United States

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226, United States

  • Heart Rhythm Associates

    Shenandoah, Texas, 77380, United States

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211, United States

  • New York University Hospital

    New York, New York, 10016, United States

  • PERC - O'Fallon

    O'Fallon, Illinois, 62269, United States

  • Pinnacle Health System

    Mechanicsburg, Pennsylvania, 17150, United States

  • Providence Hospital

    Southfield, Michigan, 48075, United States

  • Trident Medical Center

    Charleston, South Carolina, 29406, United States

  • Usman R. Siddiqui, MD

    Winter Park, Florida, 32792, United States

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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