Amulet™ ADVANCE LAA

Stroke Clinical Trial

Official title:

A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997446
• Other study ID #: ABT-CIP-10467
• Secondary ID: CRD_1056
• Status: Recruiting
• Start date: July 12, 2023
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: Abbott Medical Devices
• Contact: The ADVANCE LAA Study Team
• Phone: (651) 756-5400
• Email: ADVANCE_LAA[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. The study will enroll approximately 1000 subjects at up to 50 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bleeding
• Stroke

Intervention

Device:
• Left atrial appendage occlusion (LAAO)
Implantation of an Amplatzer Amulet left atrial appendage occluder

Locations

Country	Name	City	State
United States	Southside Hospital - Northwell Health	Bay Shore	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Roper Hospital	Charleston	South Carolina
United States	Trident Medical Center	Charleston	South Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Englewood Hospital & Medical Center	Englewood	New Jersey
United States	Baylor All Saints Medical Center at Fort Worth	Fort Worth	Texas
United States	Baptist Medical Center	Jacksonville	Florida
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Bryan Heart	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	Pinnacle Health System	Mechanicsburg	Pennsylvania
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	Winthrop-University Hospital	Mineola	New York
United States	NCH Healthcare System	Naples	Florida
United States	Vanderbilt Heart & Vascular Institute	Nashville	Tennessee
United States	New York University Hospital	New York	New York
United States	PERC - O'Fallon	O'Fallon	Illinois
United States	CHI Health Creighton University Medical Center-Bergan Mercy	Omaha	Nebraska
United States	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas
United States	Arizona Arrhythmia Research	Phoenix	Arizona
United States	Heart Rhythm Associates	Shenandoah	Texas
United States	Providence Hospital	Southfield	Michigan
United States	Stanford University Medical Center	Stanford	California
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Usman R. Siddiqui, MD	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	Composite endpoint: Ischemic stroke or systemic embolism	Composite of ischemic stroke or systemic embolism through 24 months	Through 24 months