Amulet™ ADVANCE LAA

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: Active, not recruiting
• Conditions: Stroke; Atrial Fibrillation; Bleeding
• Intervention / Treatment: Device: Left atrial appendage occlusion (LAAO)

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: Observational
• Enrollment (Actual): 610

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint: Death or complications	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	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	Composite of ischemic stroke or systemic embolism through 24 months	Through 24 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Cardiac Arrhythmia Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Hemorrhage; Investigative Techniques; Therapeutics; Catheterization; Cardiac Catheterization; Left Atrial Appendage Closure
• Other Study ID 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