Amulet™ ADVANCE LAA
A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder
2 other identifiers
observational
610
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2023
CompletedFirst Submitted
Initial submission to the registry
July 18, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
October 1, 2025
September 1, 2025
3.9 years
July 18, 2023
September 26, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Interventions
Implantation of an Amplatzer Amulet left atrial appendage occluder
Eligibility Criteria
Patients with non-valvular atrial fibrillation who are at increased risk for ischemic stroke or systemic embolism.
You may qualify if:
- 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
You may not qualify if:
- Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
Usman R. Siddiqui, MD
Winter Park, Florida, 32792, United States
PERC - O'Fallon
O'Fallon, Illinois, 62269, United States
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, 66211, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226, United States
Providence Hospital
Southfield, Michigan, 48075, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
CHI Health Creighton University Medical Center-Bergan Mercy
Omaha, Nebraska, 68124, United States
New York University Hospital
New York, New York, 10016, United States
Pinnacle Health System
Mechanicsburg, Pennsylvania, 17150, United States
Trident Medical Center
Charleston, South Carolina, 29406, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104, United States
Heart Rhythm Associates
Shenandoah, Texas, 77380, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dhanunjaya Lakkireddy, MD
Kansas City Cardiac Arrhythmia Research Foundation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2023
First Posted
August 18, 2023
Study Start
July 12, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share