Evidence map›Paper›PMID 34459659›Full record

Trial reportCirculation2021

Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial.

Dhanunjaya Lakkireddy, David Thaler, Christopher R Ellis, Vijendra Swarup, Lars Sondergaard, John Carroll, Michael R Gold, James Hermiller, Hans-Christoph Diener, Boris Schmidt and 5 more

4 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 176 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
176citing papers in PubMed, 8 pooled it
42.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02879448 nacompletednot on this map

AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial

TypeinterventionalSponsorAbbott Medical DevicesRan2016 to 2024Enrolled1,878ConditionsStrokeArmsAmulet Left Atrial Appendage Occluder, WATCHMAN Left Atrial Appendage Closure
NCT05464511 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Impact of Steerable Delivery Sheaths on Successful Closure of Left Atrial Appendage With AMULET Dual Mechanism Closure Device (STEER-CLOSE Study)

TypeinterventionalSponsorKansas City Heart Rhythm Research FoundationRan2026 to 2026Enrolled300ConditionsAtrial Fibrillation, StrokeArmsLeft atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.
NCT05560204 naenrolling by invitationnot on this mapstarted 2023, after this paper: background citation

Combined Pulsed-field Ablation (PFA) and Left Atrial Appendage Occlusion Using Watchman Flx or Amulet: A Randomized Controlled Study

TypeinterventionalSponsorPrince of Wales Hospital, Shatin, Hong KongRan2023 to 2027Enrolled200ConditionsCombined Pulsed-field Ablation (PFA)ArmsCombined Pulsed-field Ablation (PFA) + Left Atrial Appendage Occlusion (LAAO)
NCT06060912 narecruitingnot on this mapstarted 2023, after this paper: background citation

LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial

TypeinterventionalSponsorDeutsches Herzzentrum MuenchenRan2023 to 2027Enrolled226ConditionsLeft Atrial Appendage OcclusionArmsLeft Atrial Appendage Occlusion
3 · Its place in the literature

Who cites it

176 citing papers in PubMed, 8 syntheses or guidelines pooled it, 367 citations in OpenAlex.

  1. Comparative evaluation of left atrial appendage occlusion and oral anticoagulation: a Bayesian meta-analysis of randomized controlled trials.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 · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Risk factors, clinical implications, and management of peridevice leak following left atrial appendage closure: A systematic review.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Percutaneous left atrial appendage closure following catheter ablation therapy of atrial fibrillation: outcomes stratified by bleeding risk - a sub-analysis of the OPTION 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 · 2026
    Trial
  10. Trial
  11. Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.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
    Trial
  12. Article
  13. Review
  14. Review
  15. Review
  16. 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 · 2026
    Article
  17. Article
  18. Review
  19. Article
  20. Left Atrial Appendage Closure: Past, Present, and Future.The Journal of innovations in cardiac rhythm management · 2026
    Review

116 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 15 institutions in 4 countries.

Dhanunjaya LakkireddyKansas City Heart Rhythm Institute and Research Foundation, Overland Park (D.L.).ORCID 0000-0002-1492-2693
David ThalerTufts Medical Center, Boston, MA (D.T.).
Christopher R EllisVanderbilt Heart Institute, Nashville, TN (C.R.E).
Vijendra SwarupArizona Cardiovascular Research Center, Phoenix (V.S.).
Lars SondergaardRighospitalet, Copenhagen, Denmark (L.S.).
John CarrollUniversity of Colorado Hospital, Anschultz Medical Campus, Aurora (J.C.).
Michael R GoldMedical University of South Carolina, Charleston (M.R.G.).ORCID 0000-0002-4579-0216
James HermillerSt. Vincent Medical Group Inc, Indianapolis, IN (J.H.).
Hans-Christoph DienerUniversity Duisburg-Essen, Germany (H.-C.D.).ORCID 0000-0002-6556-8612
Boris SchmidtCardioangiologisches Centrum Bethanien, Frankfurt, Germany (B.S.).ORCID 0000-0001-5347-9906
Lee MacDonaldSouth Denver Cardiology Associates P.C., Littleton, CO (L.M.).
Moussa MansourMassachusetts General Hospital, Boston (M.M.).
Brijeshwar MainiDelray Medical Center, FL (B.M.).
Laura O'BrienAbbott Structural Heart, Plymouth, MN (L.O.).
Stephan WindeckerInselspital, University of Bern, Switzerland (S.W.).ORCID 0000-0003-2653-6762
Abbott Northwestern Hospital · USArizona Research Center · USCapital Cardiology Associates · USCardiovascular Center Bethanien · DEDelray Medical Center · USHeart Rhythm Society · USMassachusetts General Hospital · USMedical University of South Carolina · USRigshospitalet · DKSt. Vincent Hospital · USTufts Medical Center · USUniversity Hospital of Bern · CHUniversity of Colorado Hospital · USUniversity of Duisburg-Essen · DEVanderbilt Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPercutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device.

methodsPatients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points.

resultsA total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=-0.14 [95% CI, -3.42 to 3.13];

conclusionsThe Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02879448.

Indexed as

AgedFemaleHumansMaleSeptal Occluder DeviceStrokeanticoagulantsatrial appendageatrial fibrillationprevention & controlstroke

Identifiers

PMID34459659
PMCPMC8570346
OpenAlexW3198671937

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.