Clinical trial NCT05997446: Amulet™ ADVANCE LAA
Official title: A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Stroke
Bleeding
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation who are at increased risk for ischemic stroke or systemic embolism.

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint: Death or complications
timeFrame: Within 7 days of implant or hospital discharge, whichever is later
measure: Device closure, defined as residual jet around the device ≤ 3mm
timeFrame: Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant.
measure: Composite endpoint: Ischemic stroke or systemic embolism
timeFrame: Through 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Winter Park
country: United States
facility: Usman R. Siddiqui, MD
state: Florida
city: O'Fallon
country: United States
facility: PERC - O'Fallon
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research Foundation
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Omaha
country: United States
facility: CHI Health Creighton University Medical Center-Bergan Mercy
state: Nebraska
city: New York
country: United States
facility: New York University Hospital
state: New York
city: Mechanicsburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Heart & Vascular Institute
state: Tennessee
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center at Fort Worth
state: Texas
city: Shenandoah
country: United States
facility: Heart Rhythm Associates
state: Texas
Study officials:
affiliation: Kansas City Cardiac Arrhythmia Research Foundation
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References: