Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion.

ABSTRACT:

Background

Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.

Objective

The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort.

Methods

At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic emboli

SUBMITTER: Lakkireddy D 

PROVIDER: S-EPMC9626886 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature