Evidence map›Paper›PMID 34747186›Full record

Trial reportCirculation2022

Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial.

Roberto Galea, Federico De Marco, Nicolas Meneveau, Adel Aminian, Frédéric Anselme, Christoph Gräni, Adrian T Huber, Emmanuel Teiger, Xavier Iriart, Flora Babongo Bosombo and 8 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03399851 (Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure), which is not on this map. Cited by 69 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT03399851 naunknown statusnot on this map

Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2018 to 2026Enrolled200ConditionsLeft Atrial Appendage ClosureArmsAmplatzer Amulet for left atrial appendage closure, Watchman/FLX for left atrial appendage closure
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. 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
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Review
  9. Review
  10. 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
  11. Outcomes of Different Device Sizing Strategies Using the Newer-Generation WATCHMAN Devices for Closure of Borderline-Sized Left Atrial Appendage.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
    Article
  12. Left Atrial Appendage Closure: Past, Present, and Future.The Journal of innovations in cardiac rhythm management · 2026
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Percutaneous left atrial appendage closure for stroke prevention: current challenges and future perspectives.Clinical research in cardiology : official journal of the German Cardiac Society · 2026
    Review
  18. Article
  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Roberto GaleaDepartment of Cardiology (R.G., C.G., L.R., M.V.), Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.
Federico De MarcoDepartment of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (F.D.M., F.B.).ORCID 0000-0003-3554-6938
Nicolas MeneveauBesancon University Hospital, University of Burgundy Franche-Comté, France (N.M.).ORCID 0000-0002-1017-0463
Adel AminianDepartment of Cardiology, Centre Hospitalier Universitaire de Charleroi, Belgium (A.A.).ORCID 0000-0002-4667-9181
Frédéric AnselmeDepartment of Cardiology, University Hospital of Rouen, France (F.A.).ORCID 0000-0002-2130-9790
Christoph GräniDepartment of Cardiology (R.G., C.G., L.R., M.V.), Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.ORCID 0000-0001-6029-0597
Adrian T HuberDepartment of Diagnostic, Interventional and Pediatric Radiology (A.T.H.), Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.ORCID 0000-0001-6146-8238
Emmanuel TeigerDepartment of Cardiology, Henri-Mondor Hospital, Public Assistance Hospitals of Paris, Créteil, France (E.T.).
Xavier IriartDepartment of Pediatric and Adult Congenital Cardiology, Hôpital Cardiologique du Haut-Lévêque, CHU de Bordeaux, Bordeaux-Pessac, France (X.I.).ORCID 0000-0002-4911-7432
Flora Babongo BosomboBern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland (F.B.B., D.H.).
Dik HegBern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland (F.B.B., D.H.).
Anna FranzoneDepartment of Advanced Biomedical Sciences, University Federico II University, Naples, Italy (A.F.).
Pascal VranckxDepartment of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis; Faculty of Medicine and Life Sciences, Hasselt University, Belgium (P.V.).ORCID 0000-0002-1526-0652
Urs FischerDepartment of Neurology (U.F.),Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.ORCID 0000-0003-0521-4051
Giovanni PedrazziniCardiocentro Ticino Institute and Università della Svizzera Italiana (USI), Lugano, Switzerland (G.P., M.V.).
Francesco BedogniDepartment of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (F.D.M., F.B.).
Lorenz RäberDepartment of Cardiology (R.G., C.G., L.R., M.V.), Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.ORCID 0000-0003-0824-3026
Marco ValgimigliDepartment of Cardiology (R.G., C.G., L.R., M.V.), Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.ORCID 0000-0002-4353-7110

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure.

methodsIn the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days.

resultsBetween June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80-1.16];

conclusionsAmulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03399851.

Indexed as

Atrial AppendageAtrial FibrillationCardiac Surgical ProceduresCardiac CatheterizationEchocardiography, TransesophagealHumansTreatment Outcomeatrial appendagecomputed tomography angiography

Identifiers

PMID34747186

What OpenQuestion holds

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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.