Trial reportJACC. Clinical electrophysiology2023
Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial.
Trial report in JACC. Clinical electrophysiology, 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 20 papers, 1 of them a synthesis that pooled it.
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
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.
- Antithrombotic strategies and DOAC dosing following left atrial appendage occlusion: a network meta-analysis.European heart journal. Cardiovascular pharmacotherapy · 2026Pooled it
- Efficacy and safety of concomitant left atrial appendage closure and pulmonary vein isolation compared to left atrial appendage closure only - A meta-analysis.International journal of cardiology. Heart & vasculature · 2026Article
- 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
- Endocardial Left Atrial Appendage Occlusion in Atrial Fibrillation: Device Design, Clinical Evidence, and Postprocedural Antithrombotic Management.Medicina (Kaunas, Lithuania) · 2026Review
- Early device-related thrombosis after WATCHMAN™ FLX Pro implantation requiring surgical excision in essential thrombocythemia.Journal of cardiology cases · 2026Article
- The ABC of sealing following left atrial appendage closure.Clinical research in cardiology : official journal of the German Cardiac Society · 2026Observational
- Recurrent device-related thrombosis after left atrial appendage closure with the watchman FLX: A case report and literature review.International journal of cardiology. Cardiovascular risk and prevention · 2026Review
- Incidence and Predictors of Hypoattenuated Thickening and Device-Related Thrombus at Three Months Postprocedural CT Assessment Following Left Atrial Appendage Occlusion With Amplatzer Devices-A Single-Center Cohort.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Article
- Left Atrial Appendage Occlusion: Persistent Gaps.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
- Imaging assessment after percutaneous left atrial appendage closure: from immediate to long-term follow-up.European heart journal. Cardiovascular Imaging · 2025Review
- Percutaneous Left Atrial Appendage Closure: Supporting Evidence, Limitations and Future Directions.Journal of clinical medicine · 2025Review
- Enhanced Endothelialization Using Resveratrol-Loaded Polylactic Acid-Coated Left Atrial Appendage Occluders in a Canine Model.ACS applied bio materials · 2025Article
- Clinical effectiveness and safety comparison between direct oral anticoagulants and warfarin for nonvalvular atrial fibrillation patients following percutaneous left atrial appendage closure operation intervention: a prospective observational study.BMC pharmacology & toxicology · 2025Observational
- Advancements in 3D Transoesophageal Echocardiography (TOE) and Computed Tomography (CT) for Stroke Prevention in Left Atrial Appendage Occlusion Interventions.Journal of clinical medicine · 2024Review
- Watchman vs. Amulet for Left Atrial Appendage Closure: Current Evidence and Future Perspectives.Journal of clinical medicine · 2024Review
- "A heart within the heart": A rare case of a large left atrial appendage occluder device-related thrombus.HeartRhythm case reports · 2024Article
- 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
- Single antiplatelet therapy following Amplatzer left atrial appendage occlusion.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Observational
- Left Atrial Appendage Occlusion and Post-procedural Antithrombotic Management.Journal of clinical medicine · 2024Review
Corrections and comments
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Authors and funding
15 authors at 14 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDevice-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited.
objectivesThis analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial.
methodsSuccessful implants occurred in 903 patients with an Amulet occluder (dual occlusive mechanism device) and 885 patients with a Watchman device (single occlusive mechanism device). These patients were then followed through 18 months and DRT was assessed by transesophageal echocardiography.
resultsThe overall incidence of DRT was 3.9% (n = 70) with 3.4% (n = 30) in dual occlusive mechanism device patients and 4.8% (n = 40) in single occlusive mechanism device patients. Most DRTs (n = 19 of 31) were identified early (≤45 days) on the dual occlusive mechanism device, whereas most of the DRTs (n = 31 of 42) were identified late (>45 days) on the single occlusive mechanism device. Strong predictors of DRT included atrial fibrillation at time of procedure (HR: 2.44; 95% CI: 1.42-4.22; P < 0.01), female sex (HR: 1.65; 95% CI: 1.01-2.71; P = 0.04), and older age (HR: 1.04; 95% CI: 1.01-1.08; P = 0.02). There were no stroke events following DRT in the dual occlusive mechanism device group and 3 stroke events following DRT in the single occlusive mechanism device group. Patients with DRT were at a greater risk for cardiovascular mortality compared with non-DRT patients (8.7% vs 3.9%; HR: 2.33; 95% CI: 1.01-5.39; P = 0.04).
conclusionsIncidence of DRT following LAAO was low. Early DRTs are seen with the dual occlusive mechanism device and late DRTs are seen with the single occlusive mechanism device. Increased cardiovascular mortality risk in patients with DRT should be further investigated. (AMPLATZER Amulet LAA Occluder Trial; NCT02879448).
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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.