Abbott's Amulet 360 Linked to Low Stroke Risk at 1 Year in Late-Breaking Research

Abbott's investigational Amulet 360 left atrial appendage occluder achieved complete closure in 96.3% of patients evaluated by transesophageal echocardiography (TEE) at 1 year, with a 1.8% incidence of ischemic stroke or systemic embolism, according to late-breaking results from the VERITAS study presented at Transcatheter Cardiovascular Therapeutics (TCT) 2026.¹

The prospective, single-arm study included 458 patients with nonvalvular atrial fibrillation (AF) at increased risk for thromboembolism who were seeking an alternative to long-term oral anticoagulation. At 12 months, complete left atrial appendage (LAA) closure was observed in 91.1% of patients when assessed using either TEE or cardiac computed tomography (CT), while clinically relevant device-related thrombus occurred in 0.4%.¹

The findings were presented November 1, 2026, at TCT in San Diego, California, and simultaneously published in JACC: Cardiovascular Interventions. The next-generation device, which remains investigational in the United States, is designed to improve procedural ease of use and accommodate a broader range of LAA anatomies while maintaining effective closure.¹˒²

"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," Dhanunjaya Lakkireddy, MD, executive medical director of the Kansas City Heart Rhythm Institute, professor of medicine at the University of Missouri, and president-elect of the Heart Rhythm Society, said in an Abbott press release.²

"The VERITAS trial results are highly encouraging, demonstrating high rates of complete closure sustained through 12 months. These findings reinforce the potential of the Amulet 360 technology to provide physicians with an effective treatment option as we continue to advance strategies for stroke risk reduction in this patient population," Lakkireddy continued.²

VERITAS Evaluates Stroke Prevention Alternative in High-Risk AF

VERITAS (NCT06707688) is an ongoing, prospective, multicenter, single-arm study evaluating the safety and effectiveness of the next-generation Amulet 360 device in patients with nonvalvular AF at increased thromboembolic risk who have a clinical rationale for pursuing a nonpharmacologic alternative to oral anticoagulation.¹

Between November 2024 and August 2025, investigators enrolled 458 patients, including 58 roll-in participants, across 34 centers in the United States, Canada, and Europe.

Participants had a mean age of 74.0 years, and 38.4% were women. The mean CHA₂DS₂-VASc score was 4.1, indicating elevated thromboembolic risk, while the mean HAS-BLED score was 3.2. A history of stroke was reported in 15.3% of patients, and 22.9% had a history of major bleeding.¹

Implantation was successful in 455 of 458 patients (99.3%). Among patients eligible for the 1-year assessment, 425 of 438 (97.0%) completed follow-up, with a median follow-up duration of 365 days.

Amulet 360 builds on Abbott's previously approved Amplatzer Amulet device, incorporating a more conformable lobe, shorter redesigned stabilizing anchors, and a dual-row anchoring configuration intended to improve device placement and accommodate different LAA anatomies.

Complete Closure Observed in More Than 90% of Patients

At 1 year, complete LAA closure, defined as the absence of peridevice leak, was observed in 359 of 394 patients (91.1%; 95% CI, 87.9%-93.7%) evaluated using TEE or cardiac CT. Among the 267 patients assessed using TEE alone, 257 (96.3%; 95% CI, 93.2%-98.2%) achieved complete closure.¹

Small peridevice leaks measuring greater than 0 mm to 3 mm were observed in 4.6% of patients across both imaging modalities, while leaks exceeding 3 mm occurred in 4.3%. All larger leaks were detected using cardiac CT.

Investigators noted that cardiac CT is more sensitive than TEE for identifying residual contrast flow around or through implanted devices. Of the 17 patients with leaks greater than 3 mm detected by CT at 1 year, 13 had demonstrated complete closure on TEE at 45 days.

No patient with a peridevice leak identified on 1-year imaging experienced a neurological event during follow-up.¹

Device-related thrombus was identified in 15 patients, corresponding to a cumulative incidence of 3.3% (95% CI, 2.0%-5.3%). However, only 2 cases (0.4%; 95% CI, 0.1%-1.5%) were considered clinically relevant, defined by escalation to oral anticoagulation or an associated clinical event.

One clinically relevant thrombus occurred in a patient with a history of metastatic breast cancer who subsequently required oral anticoagulation. The second occurred in association with cardiothoracic surgery and was followed by an ischemic stroke.

Stroke Incidence Remained Below 2% at 1 Year

The cumulative incidence of ischemic stroke or systemic embolism was 1.8% (95% CI, 0.8%-3.3%) at 1 year. Eight ischemic strokes were reported, with 7 occurring during the first 6 months after implantation. No systemic embolic events were reported.¹

Other clinical outcomes through 1 year included:

• All-cause mortality: 3.9% (95% CI, 2.4%-6.3%).
• Cardiovascular mortality: 1.9% (95% CI, 0.9%-3.8%).
• Major bleeding: 6.6% (95% CI, 4.5%-9.2%).
• Pericardial effusion requiring intervention: 0.9% (95% CI, 0.3%-2.1%).
• Device embolization: 0%.

Major bleeding occurred in 29 patients, with most events involving gastrointestinal bleeding or vascular access sites. Five bleeding events were procedure-related, including 4 vascular access hematomas and 1 pericardial tamponade.¹

The investigators noted that most bleeding events occurred early in follow-up, when patients were predominantly receiving dual antiplatelet therapy (DAPT). The study protocol directed patients to receive DAPT for 6 months, followed by single antiplatelet therapy indefinitely.

Adherence to the prescribed antithrombotic regimen exceeded 85% through 1 year, while oral anticoagulation use remained below 6%. When oral anticoagulation was initiated, it was generally for temporary clinical indications, most commonly following cardiac ablation procedures.¹

Implications for AF Stroke Prevention in Primary Care

The findings provide additional evidence on the safety and effectiveness of LAA occlusion as a potential stroke prevention strategy for patients with nonvalvular AF who are not appropriate candidates for long-term oral anticoagulation.

For primary care physicians, who frequently manage AF and its associated cardiovascular comorbidities, the findings highlight the importance of individualized stroke and bleeding risk assessment when evaluating treatment options.

Although oral anticoagulation remains first-line therapy for stroke prevention in most eligible patients with AF, percutaneous LAA occlusion may be considered in selected patients with elevated thromboembolic risk who have contraindications to long-term anticoagulation or a high risk of major bleeding.

The VERITAS population reflected this clinical challenge, with elevated baseline CHA₂DS₂-VASc and HAS-BLED scores and nearly 1 in 4 participants reporting a history of major bleeding.

However, the investigators emphasized that VERITAS was a single-arm study without a randomized comparator. Consequently, the observed rates of stroke, bleeding, and device-related complications cannot establish superiority or noninferiority compared with oral anticoagulants or other LAA occlusion devices.¹

The study was also conducted by experienced LAA occlusion operators, potentially limiting the generalizability of the findings to centers with less procedural experience. Additionally, the analysis was limited to 1 year of follow-up, and longer-term data are needed to assess the durability of LAA closure and stroke prevention.

Abbott reported that Amulet 360 received CE Mark approval in August 2026 but remains approved for investigational use only in the United States.²

The investigators concluded that the 1-year VERITAS results support the safety and effectiveness of the next-generation dual-seal LAA occluder in selected patients with nonvalvular AF seeking an alternative to long-term oral anticoagulation. Additional follow-up is planned to evaluate longer-term clinical outcomes.

References

1. Lakkireddy D, Makkar A, Alkhouli M, et al. 1-year safety and effectiveness of a next-generation dual-seal left atrial appendage occluder. JACC Cardiovasc Interv. Published online November 1, 2026. doi:10.1016/j.jcin.2026.10.023.
2. Abbott. Late-breaking one-year data show Abbott's next-generation Amulet 360 device continues to demonstrate high rates of left atrial appendage closure and low incidence of stroke. News release. November 2, 2026.