ArticleJACC. Asia2025
A Membrane Modification Technique for Left Atrial Appendage Occlusion: A Multicenter Randomized Controlled Trial.
Article in JACC. Asia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04429646 (A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the LAMax LAA Closure System Compared to the Watchman® LAAC Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Ischemic Stroke), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the LAMax LAA Closure System Compared to the Watchman® LAAC Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Ischemic Stroke
Who cites it
3 citing papers in PubMed.
- Endocardial Left Atrial Appendage Occlusion in Atrial Fibrillation: Device Design, Clinical Evidence, and Postprocedural Antithrombotic Management.Medicina (Kaunas, Lithuania) · 2026Review
- Review
- The Search for an Ideal Left Atrial Appendage Occluder.JACC. Asia · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe previously pioneered a negatively ionized polyethylene terephthalate membrane method (the SMART technique) with the LAMax (test) occluder to reduce platelet adhesion and promote endothelialization.
objectivesThis study aimed to compare the safety and efficacy of the test occluder with the Watchman 2.5 device (control) in patients with nonvalvular atrial fibrillation to reduce stroke risk.
methodsOverall, 236 patients were randomly assigned (1:1) (open-label) to the test or control device for left atrial appendage occlusion (LAAO). The effectiveness endpoints included 12-month successful left atrial appendage (LAA) sealing with residual flow ≤5 mm and clinical success (composite of ischemic stroke, transient ischemic attack, and systemic embolism). Safety endpoints were also studied. A noninferiority margin of -7% was set between the devices.
resultsThe test device was noninferior to the control device for the effectiveness endpoints of successful LAA sealing (test 93.2% vs control 89.8%; P < 0.05) and clinical success (test 93.2% vs control 89.8%; P < 0.05). The 12-month safety endpoints were similar between the 2 devices. The device-related thrombus rates for the control device at the 3- and 12-month visits were 5.7% and 4.6%, respectively; no cases of device-related thrombus occurred with the test device.
conclusionsThis study suggests that transcatheter LAAO using the SMART technique may effectively and safely prevent stroke in patients with nonvalvular atrial fibrillation. Although further studies with larger sample sizes are needed, this novel technique may prevent device-related thrombus formation and has high potential for application in interventional therapies. (LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke; NCT04429646).
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