Amulet™ ADVANCE LAA

N/AActive Not RecruitingNCT05997446

Abbott Medical Devices610 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

610

Conditions

Atrial Fibrillation Stroke Bleeding

Interventions

Left atrial appendage occlusion (LAAO)DEVICE

Implantation of an Amplatzer Amulet left atrial appendage occluder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Arizona Arrhythmia Research

Phoenix, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Through 24 months

Data from ClinicalTrials.gov

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