Amulet™ ADVANCE LAA

Running, not enrolling

Conditions studied: Atrial Fibrillation, Stroke, Bleeding

In brief

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.

Key facts

Study ID

NCT05997446

Run by

Abbott Medical Devices

People needed

610

Starts

2023-07-12

Expected to finish

2027-06-01

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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