Amulet™ ADVANCE LAA

September 26, 2025 updated by: Abbott Medical Devices

A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder

This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
610

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Arrhythmia Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
      • Winter Park, Florida, United States, 32792
        • Usman R. Siddiqui, MD
    • Illinois
      • O'Fallon, Illinois, United States, 62269
        • PERC - O'Fallon
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Cardiac Arrhythmia Research Foundation
      • Wichita, Kansas, United States, 67226
        • Cardiovascular Research Institute of Kansas
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Providence Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Heart
      • Omaha, Nebraska, United States, 68124
        • CHI Health Creighton University Medical Center-Bergan Mercy
    • New York
      • New York, New York, United States, 10016
        • New York University Hospital
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, United States, 17150
        • Pinnacle Health System
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Trident Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Heart & Vascular Institute
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Baylor All Saints Medical Center at Fort Worth
      • Shenandoah, Texas, United States, 77380
        • Heart Rhythm Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite endpoint: Death or complications
Time Frame: Within 7 days of implant or hospital discharge, whichever is later
Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later
Within 7 days of implant or hospital discharge, whichever is later
Device closure, defined as residual jet around the device ≤ 3mm
Time Frame: Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant.
Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory
Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant.
Composite endpoint: Ischemic stroke or systemic embolism
Time Frame: Through 24 months
Composite of ischemic stroke or systemic embolism through 24 months
Through 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Cardiac Arrhythmia Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABT-CIP-10467
  • CRD_1056 (Other Identifier: Abbott Medical Devices)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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