Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2023
Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.
Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02879448 (AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial), which is not on this map. Cited by 16 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.
AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial
Who cites it
16 citing papers in PubMed, 27 citations in OpenAlex.
- Outcomes of Amulet occluder implantation following Watchman screen failure in the ADVANCE LAA study: a real-world analysis of procedural success and safety.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Left Atrial Appendage Electrical Isolation Reduces Residual Patency After Device Closure in Patients With Persistent Atrial Fibrillation.Journal of the American Heart Association · 2026Article
- Outcomes of simplified left atrial appendage occlusion using the WATCHMAN FLX device: the ROSE-FLX study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- CT-based radiomics to predict peri-device leakage after left atrial appendage closure.BMC medical imaging · 2026Article
- Left Atrial Appendage Closure in Patients with Atrial Fibrillation and Intermediate-to-Borderline High Cardiovascular Risk: A Retrospective Propensity Match Cohort Study.Journal of cardiovascular development and disease · 2026Article
- Left atrial appendage closure devices: a contemporary review of techniques, tips and tricks.Frontiers in cardiovascular medicine · 2026Review
- Update on left atrial appendage closure for neurologists.European stroke journal · 2026Review
- Impact of Immunosuppressive Drugs on Patients With Percutaneous Left Atrial Appendage Occlusion.Journal of cardiovascular electrophysiology · 2025Article
- 2025 SCAI/HRS Clinical Practice Guidelines on Transcatheter Left Atrial Appendage Occlusion.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Article
- SCAI/HRS Technical Review on Transcatheter Left Atrial Appendage Occlusion.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Article
- Comparative outcomes of left atrial appendage occlusion with and without catheter ablation: a 5-year propensity-matched analysis.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Article
- Steerable Delivery Sheath for Optimized LAA Closure: First Experience and Procedural Outcomes.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Article
- Preprocedural 3D Transesophageal Echocardiography for the Prediction of Device Deformation Morphology and Peri-Device Leaks After Transcatheter Left Atrial Appendage Occlusion with the AmplatzerJournal of clinical medicine · 2025Article
- Comparison of prognosis and analysis of related risk factors among three different left atrial appendage occlusion procedures in patients with atrial fibrillation.Frontiers in cardiovascular medicine · 2025Article
- Comparative Profiles of the WATCHMAN™ and Amplatzer™ Cardiac Plug/Amplatzer™ Amulet™ Devices for Left Atrial Appendage Closure in Non-valvular Atrial Fibrillation: A Comprehensive Systematic Review and Meta-analysis.The Journal of innovations in cardiac rhythm management · 2024Review
- Practical guide on left atrial appendage closure for the non-implanting physician: an international consensus paper.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 10 institutions in 3 countries.
Funding
Abstract
aimsIncomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis. METHODS AND
resultsAn independent core lab analysed all images for the presence or absence of severe PDL (>5 mm). The incidence, mechanistic factors, predictors using propensity score-matched controls, and evolution of severe PDLs through 18 months were assessed. Of the 1878 patients randomized in the trial, the Amulet occluder had significantly fewer severe PDLs than the Watchman device at 45 days (1.1 vs. 3.2%, P < 0.001) and 12 months (0.1 vs. 1.1%, P < 0.001). Off-axis deployment or missed lobes were leading mechanistic PDL factors in each device group. Larger left atrial appendage (LAA) dimensions including orifice diameter, landing zone diameter, and depth predicted severe PDL with the Watchman device, with no significant anatomical limitations noted with the Amulet occluder. Procedural and device implant predictors were found with the Amulet occluder attributed to the learning curve with the device. A majority of Watchman device severe PDLs did not resolve over time through 18 months.
conclusionThe dual-occlusive Amplatzer Amulet LAA occluder provided improved LAA closure compared with the Watchman 2.5 device. Predictors and temporal observations of severe PDLs were identified in the Amulet IDE trial. CLINICAL
trial registrationhttps://clinicaltrials.gov Unique identifier NCT02879448.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.