Evidence map›Paper›PMID 32763967›Full record

ArticleOpen heart2020

Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study.

Philippe Garot, Xavier Iriart, Adel Aminian, Joelle Kefer, Xavier Freixa, Ignacio Cruz-Gonzalez, Sergio Berti, Liesbeth Rosseel, Reda Ibrahim, Kasper Korsholm and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Open heart, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04180605 (The Value of FEops HEARTguideTM Patient-Specific Computational Simulation in the Planning of Percutaneous Left Atrial Appendage Closure With the AmplatzerTM AmuletTM Device), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.1field-weighted citation impact, top 7% 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.

NCT04180605 naunknown statusnot on this map

The Value of FEops HEARTguideTM Patient-Specific Computational Simulation in the Planning of Percutaneous Left Atrial Appendage Closure With the AmplatzerTM AmuletTM Device (PREDICT-LAA)

TypeinterventionalSponsorRigshospitalet, DenmarkRan2020 to 2022Enrolled200ConditionsAtrial Fibrillation, Stroke PreventionArmsAdditional support for preoperative planning of LAA closure procedures, Left atrial appendage closure
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 33 citations in OpenAlex.

  1. AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2025
    Review
  2. Review
  3. Review
  4. Review
  5. Measure twice, implant once.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Article
  6. Article
  7. Article
  8. Left atrial appendage occlusion.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Left atrial appendage occlusion in COVID-19 times.European heart journal supplements : journal of the European Society of Cardiology · 2020
    Article
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 8 countries.

Philippe GarotDepartment of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, Île-de-France, France.
Xavier IriartPediatric and Congenital Cardiology, University Hospital of Bordeaux, Pessac, MS, France.
Adel AminianDepartment of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Hainaut, Belgium.
Joelle KeferDivision of Cardiology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Xavier FreixaCardiovascular Institute, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain.
Ignacio Cruz-GonzalezDepartment of Cardiology, Hospital Clínico Universitario de Salamanca, Salamanca, Spain.
Sergio BertiCardiology Unit, Fondazione CNR Regione Toscana, Massa, Italy.
Liesbeth RosseelDepartment of Cardiology, University Hospital Galway, Galway, Ireland.
Reda IbrahimDepartment of Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada.
Kasper KorsholmDepartment of Cardiology, Aarhus Universitetshospital Skejby, Aarhus, Denmark.
Jacob OdenstedtDepartment of Cardiology, Sahlgrenska University Hospital, Goteborg, Sweden.
Jens-Erik Nielsen-KudskDepartment of Cardiology, Aarhus Universitetshospital Skejby, Aarhus, Denmark.
Jaqueline SawDepartment of Cardiology, Vancouver General Hospital, Vancouver, British Columbia, Canada.
Lars SondergaardDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Ole De BackerDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark ole.debacker@gmail.com.ORCID 0000-0002-9674-0278
Aarhus University · DKRigshospitalet · DKCliniques Universitaires Saint-Luc · BEComplejo Hospitalario de Salamanca · ESFondazione Toscana Gabriele Monasterio · ITGrand Charleroi Hospital · BEHospital Clínic de Barcelona · ESInstitut Cardiovasculaire Paris Sud · FRMontreal Heart Institute · CASahlgrenska University Hospital · SEUniversité de Bordeaux · FRUniversity Hospital Galway · IEVancouver General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOptimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA).

designThe PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.

conclusionThe objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04180605).

Indexed as

Patient-Specific ModelingTherapy, Computer-AssistedTomography, X-Ray ComputedAtrial AppendageAtrial FibrillationAtrial Function, LeftCanadaCardiac CatheterizationEuropeHeart RateHumansMulticenter Studies as TopicPredictive Value of TestsProspective StudiesRandomized Controlled Trials as TopicTreatment Outcomeatrial fibrillationCT scanningdevice closurestroke

Identifiers

PMID32763967
PMCPMC7412609
OpenAlexW3048302577

What OpenQuestion holds

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LicenceCC BY-NC
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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.