Amulet™ ADVANCE LAA

Last updated: July 30, 2024
Sponsor: Abbott Medical Devices
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Chest Pain

Atrial Fibrillation

Treatment

Left atrial appendage occlusion (LAAO)

Clinical Study ID

NCT05997446
ABT-CIP-10467
CRD_1056
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 testingassociated with this clinical study

Exclusion

Exclusion Criteria:

  • Presence of other conditions that, in the investigator's opinion, could limit thesubject's ability to participate in follow-up

Study Design

Total Participants: 610
Treatment Group(s): 1
Primary Treatment: Left atrial appendage occlusion (LAAO)
Phase:
Study Start date:
July 12, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Arizona Arrhythmia Research

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Arkansas Heart Hospital

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • San Diego Cardiac Center

    San Diego, California 92123
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Baptist Hospital of Miami

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Baptist Medical Center

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • NCH Healthcare System

    Naples, Florida 34102
    United States

    Site Not Available

  • Usman R. Siddiqui, MD

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Kootenai Heart Clinics

    Coeur d'Alene, Idaho 83814
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • PERC - O'Fallon

    O'Fallon, Illinois 62269
    United States

    Site Not Available

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Bryan Heart

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • CHI Health Creighton University Medical Center-Bergan Mercy

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Englewood Hospital & Medical Center

    Englewood, New Jersey 07631
    United States

    Site Not Available

  • Southside Hospital - Northwell Health

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Winthrop-University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • New York University Hospital

    New York, New York 10016
    United States

    Site Not Available

  • Pinnacle Health System

    Mechanicsburg, Pennsylvania 17150
    United States

    Site Not Available

  • Roper Hospital

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Trident Medical Center

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Baylor All Saints Medical Center at Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Heart Rhythm Associates

    Shenandoah, Texas 77380
    United States

    Site Not Available

  • Aurora Medical Group

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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