Status:

ACTIVE_NOT_RECRUITING

Amulet™ ADVANCE LAA

Lead Sponsor:

Abbott Medical Devices

Conditions:

Atrial Fibrillation

Stroke

Eligibility:

All Genders

18+ years

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 enrol...

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 r...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

July 12 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2027

Estimated Enrollment :

610 Patients enrolled

Trial Details

Trial ID

NCT05997446

Start Date

July 12 2023

End Date

June 1 2027

Last Update

October 1 2025

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Arizona Arrhythmia Research

Phoenix, Arizona, United States, 85016

2

Arkansas Heart Hospital

Little Rock, Arkansas, United States, 72211

3

Baptist Medical Center

Jacksonville, Florida, United States, 32207

4

Usman R. Siddiqui, MD

Winter Park, Florida, United States, 32792

Amulet™ ADVANCE LAA | DecenTrialz