Abstract
Percutaneous left atrial appendage occlusion (LAAO) is an alternative stroke prevention strategy in atrial fibrillation patients deemed unsuitable to tolerate long-term oral anticoagulation. Although current LAAO devices have been shown to provide stroke protection, they have been associated with peridevice leak and pericardial effusion. The VERITAS study evaluates the safety and effectiveness of Abbott's next-generation dual-seal LAAO device.
The purpose of this study was to assess the VERITAS primary endpoints and key clinical outcomes through 45 days.
In this prospective, global, multicenter, single-arm study, atrial fibrillation patients with CHA
DS
-VASc ≥2 for men and ≥3 for women underwent LAAO with the next-generation dual-sealing device (Amulet 360). The primary safety endpoint included key adverse events through 7 days postprocedure or hospital discharge, whichever was later. The primary effectiveness endpoint was LAAO (leak ≤5 mm) by 45-day transesophageal echocardiography, assessed by an independent core laboratory.
Across 34 global sites, 400 patients (age 73.8 ± 7.4 years, 62% men, CHA
DS
-VASc 4.1 ± 1.4, and HAS-BLED 3.1 ± 1.0) were enrolled and underwent an implant attempt. LAAO implant success was 99.8% (399 of 400). The incidence for the primary safety endpoint was 0.0% (0 of 400). All (100%) patients assessed with echocardiography met the primary effectiveness endpoint. At 45 days, complete LAAO (0 mm leak) was observed in 93.9% of patients. Two (0.5%) patients required percutaneous draining for pericardial effusions and device-related thrombus was observed in 2.4% of patients.
The VERITAS study demonstrates high implant success of the next-generation dual-seal LAAO device, and a favorable short-term safety and sealing profile. (Abbott Medical-VERITAS Study; NCT06707688).