Stroke Clinical Trial - Amulet™ ADVANCE LAA

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05997446
Study type	Observational
Source	Abbott Medical Devices
Contact	The ADVANCE LAA Study Team
Phone	(651) 756-5400
Email	ADVANCE_LAA@abbott.com
Status	Recruiting
Phase
Start date	July 12, 2023
Completion date	June 2027

View Details

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