HealthTech
Abbott Reports One-Year VERITAS Study Results for Amulet 360
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The one-year VERITAS study of Abbott’s investigational Amulet 360 left atrial appendage occluder reported complete closure, defined as a 0 mm peridevice leak, in 91.1% of patients assessed by either transesophageal echocardiography (TEE) or cardiac computed tomography (CT). The results were presented on November 1, 2026, at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego and published online the same day in JACC: Cardiovascular Interventions.
Abbott announced the findings on November 2, 2026. The official TCT program identifies Dhanunjaya Lakkireddy as the presenter of the late-breaking clinical science presentation on the study.
VERITAS is a prospective, global, multicenter, single-arm premarket study sponsored and funded by Abbott. It enrolled 458 patients, comprising 58 roll-in and 400 primary-analysis patients, between November 2024 and August 2025 at 34 centers in the United States, Canada and Europe. Participants had nonvalvular atrial fibrillation, increased thromboembolism risk and an appropriate rationale for seeking a nonpharmacologic alternative to oral anticoagulation. The cohort’s mean age was 74.0 years, and 38.4% of patients were female. Mean CHA2DS2-VASc and HAS-BLED scores, used to assess stroke and bleeding risk, were 4.1 and 3.2, respectively. Of 438 patients eligible for the one-year visit after study exits, 425 completed it; median follow-up was 365 days.
One-Year Imaging and Clinical Outcomes
An independent core laboratory reviewed cardiac imaging for peridevice leaks and device-related thrombus. One-year imaging used TEE in 267 patients and cardiac CT in 127. The investigators reported complete closure in 96.3% of patients assessed by TEE alone. All 17 leaks greater than 3 mm were observed on cardiac CT, and no patient with any leak on one-year imaging experienced a neurological event.
The paper reported these one-year clinical outcomes, with major bleeding defined as Bleeding Academic Research Consortium type 3 or greater:
| Outcome | Rate |
|---|---|
| All-cause mortality | 3.9% |
| Cardiovascular mortality | 1.9% |
| Ischemic stroke or systemic embolism | 1.8% |
| Major bleeding | 6.6% |
| Pericardial effusion requiring intervention | 0.9% |
| Device embolization | 0% |
The independent clinical events committee adjudicated all 16 deaths as unrelated to the device or procedure. No systemic embolism was reported. Of 29 major bleeding events, five were procedure-related; most bleeds were gastrointestinal or vascular-access-site in origin and occurred early in follow-up, when patients were predominantly receiving dual antiplatelet therapy.
Device-related thrombus was reported cumulatively in 3.3% of patients, with 0.4% deemed clinically relevant under the study’s post-hoc definition. That definition covered patients escalated to oral anticoagulation or who experienced clinical sequelae.
Adherence to the protocol-directed regimen of dual antiplatelet therapy through six months followed by single antiplatelet therapy indefinitely remained above 85% through one year. Oral anticoagulant use stayed below 6% and was generally associated with temporary clinical indications, most commonly cardiac ablation.
Device Design and Study Limits
Abbott describes Amulet 360 as a minimally invasive, dual-seal device delivered through a leg vein to close the left atrial appendage in clinically appropriate patients seeking an alternative to long-term blood-thinning medication. Its lobe is softer and more conformable than the previous-generation device, while an outer disc provides a second sealing layer. The study also describes a dual row of shorter, redesigned stabilizing anchors.
“For patients with non-valvular atrial fibrillation who require an alternative to long-term oral anticoagulation, achieving durable and complete left atrial appendage closure is an important clinical goal,” Lakkireddy said in Abbott’s announcement.
Amulet 360 received CE Mark approval in August 2026 and is approved for investigational use only in the United States. It builds on Abbott’s Amplatzer Amulet occluder, which has been used in Europe since 2013 and in the United States since 2021.
The investigators cautioned that VERITAS had no control group, so its outcomes cannot be directly compared with other occlusion devices or anticoagulants. They said the inclusion criteria and use of experienced operators could limit generalizability, and the study was not powered to identify predictors of individual clinical outcomes. Longer-term follow-up is needed to assess durable stroke prevention and will be reported in future publications, according to the investigators.
