The Amulet™ 360 Left Atrial Appendage Occluder is available for sale in EUROPE.
Caution: investigational device. Limited by Federal (or United States) law to investigational use.
The Amulet™ 360 LAA Occluder is a dual-seal design made of two primary components.
- A conformable lobe that fills and closes the appendage
- A disc that creates a seal at the LAA ostium
CLEAR Concomitant Study: Early safety and effectiveness results of Abbott PFA and LAAO procedure1
CLEAR is a prospective multicenter study evaluating the feasibility, safety, and effectiveness of a concomitant procedure with Volt PFA for atrial fibrillation (AF) treatment and LAA occlusion with next-generation dual-seal device, Amulet 360. Study subjects are patients with non-valvular AF who are indicated for both AF ablation and LAA occlusion (LAAO) and were released on a standardized post-procedure OAC regimen at discharge.
This early experience in the first 68 patients of the study, presented at APHRS 2026, provides insights into feasibility of a standardized concomitant workflow.
7-day Safety
0%
Primary safety event rate
No death, ischemic stroke, systemic embolism, or device/procedure-related complication requiring major intervention
Procedural Findings
100%
- Acute PV Isolation Success with Volt PFA system
- Amulet 360 Left Atrial Appendage Occluder Implant Success
n=68/68
Average Procedure Time & Sedation Workflow
51.7 minutes (± 22.1)
Procedure time reported as Access-to- venous close, including PV Isolation and LAA Closure
37%
Of procedures completed without General Anesthesia
Closure: In procedure
100%
Acute Complete Closure (0mm leak)
Including in patients with
Complex LAA morphology
(72% chicken wing or multi-lobe)
The VERITAS Study
The VERITAS Study2: early outcomes (45-day)
First results from the VERITAS Study were presented at AF Symposium 2026, providing the earliest clinical evidence evaluating the Amulet™ 360 LAAO* in patients with nonvalvular AF. The findings show that both primary endpoints were met with statistically significant performance, supported by independent core lab review.
Study outcomes
Early findings from the VERITAS Study, provided the first data on the safety, effectiveness, and early closure performance for the Amulet™ 360 LAAO*.
Safety and effectiveness endpoints
0%
p < 0.0001 (n=0/400)
Primary safety endpoint**
(performance goal: 3.75%)
100%
p < 0.0001 (n=396/396)
Primary effectiveness***
endpoint (performance goal: 96.6%)
Closure assessment at 45-days: independent core lab observe
100%
Clinically relevant closure (no PDL >3mm identified)
93.9%
Complete closure (0mm leak) on 45-day follow up TEE
Procedural metrics
99.8%
Implant success
88%
Of subjects implanted with a single device attempt
0.5%
Pericardial effusion requiring drainage
0%
Device embolization
* Previously reported data.
** Primary safety endpoint was key adverse events (death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular Intervention) through 7 days post-procedure or hospital discharge, whichever was later.
***Primary effectiveness endpoint: LAA occlusion defined as no peri-device flow or peri-device flow ≤ 5 mm based on Doppler color flow TEE at the 45-day follow-up visit as assessed by an independent core laboratory.
Impact of procedural experience of a next generation LAAO device - insights from the VERITAS Study3
Key takeaways
- 100% implant success after implanters 5th case
- Complete closure (0 mm leak) in majority of cases, from roll-ins (84.3%) to experienced users, defined as those with 5+ procedures (96.1%)
- Procedural time decreased with implanter experience
100%
Peri-device leak ≤3 mm regardless of experience
96.1%
Complete closure (0 mm leak) in experienced group
The Amulet™ 360 Left Atrial Appendage Occluder is available for sale in EUROPE.
Caution: investigational device. Limited by Federal (or United States) law to investigational use.
- Nair, D, Reddy, V, et al. Concomitant Balloon-in-Basket Pulsed Field Ablation and Next-Generation Left Atrial Appendage Occlusion: First Results from the Prospective Multicenter CLEAR study, EP Europace, Published online October 2026. https://www.doi.org/10.1093/europace/euag299
- Nair, D., Freixa, X., Ellis, C. R., Lakkireddy, D., Nielsen-Kudsk, J. E., Horton, R., Reddy, V. Y., & the VERITAS Investigators. (2026). Early outcomes with a next-generation dual-seal left atrial appendage occluder: Results from the VERITAS study. JACC: Clinical Electrophysiology, 12(6).
- Nair D, Lakkireddy, D, Alkhouli, M, et al. Impact of Procedural Experience of a Next Generation Left Atrial Appendage Occlusion Device – Insights from the VERITAS Study. Presented by Dr. Devi Nair at NY Valves; June 26, 2026; New York, NY USA.
Rx Only. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.
MAT-2623073 v4.0