Arrhythmias & electrophysiology

Early Outcomes With a Next-Generation Dual-Seal Left Atrial Appendage Occluder: Results From the VERITAS Study

JACC Clin ElectrophysiolPublished prospective, global, multicenter, single-arm study

Authors' conclusion

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).

Study context

Population
Atrial fibrillation patients with CHA2DS2-VASc ≥2 for men and ≥3 for women undergoing left atrial appendage occlusion (LAAO) with the next-generation dual-sealing deviceenrolled and underwent an implant attempt
Participants
400 patients
Outcome
Primary effectiveness endpoint: LAAO (leak ≤5 mm) by transesophageal echocardiography, independent core laboratory
Follow-up
45 days
Methodological details34 global sites, independent core laboratory assessment of transesophageal echocardiography
  • 34 global sites
  • Independent core laboratory assessment of transesophageal echocardiography

Main finding

As reported in the abstract

Amulet 360

100%

Observational data: associations, not effects.

Further findings

OutcomeValues
LAAO implant successAmulet 360 99.8%
Complete LAAO (0 mm leak) · 45 daysAmulet 360 93.9%

Baseline characteristics

Age
73.8 ± 7.4 years
Men
62%
CHA2DS2-VASc
4.1 ± 1.4
HAS-BLED
3.1 ± 1.0

Safety

OutcomeValues
Primary safety endpoint: key adverse events through 7 days postprocedure or hospital discharge, whichever was laterPrimary safety endpointAmulet 360 0.0%
Pericardial effusion requiring percutaneous drainingAmulet 360 0.5%
Device-related thrombusAmulet 360 2.4%

Original publication

Early Outcomes With a Next-Generation Dual-Seal Left Atrial Appendage Occluder: Results From the VERITAS Study. JACC Clin Electrophysiol. Published 6 February 2026. doi:10.1016/j.jacep.2026.01.021

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