Amulet™ ADVANCE LAA

NCT ID: NCT05997446

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-12

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Stroke Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Left atrial appendage occlusion (LAAO)

Implantation of an Amplatzer Amulet left atrial appendage occluder

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dhanunjaya Lakkireddy, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City Cardiac Arrhythmia Research Foundation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Arrhythmia Research

Phoenix, Arizona, United States

Site Status

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status

Baptist Medical Center

Jacksonville, Florida, United States

Site Status

Usman R. Siddiqui, MD

Winter Park, Florida, United States

Site Status

PERC - O'Fallon

O'Fallon, Illinois, United States

Site Status

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, United States

Site Status

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

Site Status

Providence Hospital

Southfield, Michigan, United States

Site Status

Bryan Heart

Lincoln, Nebraska, United States

Site Status

CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, United States

Site Status

New York University Hospital

New York, New York, United States

Site Status

Pinnacle Health System

Mechanicsburg, Pennsylvania, United States

Site Status

Trident Medical Center

Charleston, South Carolina, United States

Site Status

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, United States

Site Status

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, United States

Site Status

Heart Rhythm Associates

Shenandoah, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRD_1056

Identifier Type: OTHER

Identifier Source: secondary_id

ABT-CIP-10467

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Amplatzer Amulet LAAO vs. NOAC
NCT04226547 ACTIVE_NOT_RECRUITING NA
Abbott Medical - VERITAS Study
NCT06707688 ACTIVE_NOT_RECRUITING NA
Zenith LAA Occlusion System
NCT05951101 RECRUITING NA