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

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Philippe Garot, Institut Cardiovasculaire Paris Sud
  • ,
  • Xavier Iriart, CHU Hôpitaux de Bordeaux
  • ,
  • Adel Aminian, Centre Hospitalier Universitaire de Charleroi
  • ,
  • Joelle Kefer, Université catholique de Louvain
  • ,
  • Xavier Freixa, University of Barcelona
  • ,
  • Ignacio Cruz-Gonzalez, Hospital Clínico Universitario de Salamanca
  • ,
  • Sergio Berti, Fondazione CNR Regione Toscana
  • ,
  • Liesbeth Rosseel, Saolta University Health Care Group
  • ,
  • Reda Ibrahim, University of Montreal
  • ,
  • Kasper Korsholm
  • Jacob Odenstedt, University of Gothenburg
  • ,
  • Jens Erik Nielsen-Kudsk
  • Jaqueline Saw, University of British Columbia
  • ,
  • Lars Søndergaard, Rigshospitalet
  • ,
  • Ole De Backer, Københavns Universitet

Background Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA). Design The 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. Conclusion The 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).

OriginalsprogEngelsk
Artikelnummere001326
TidsskriftOpen Heart
Vol/bind7
Nummer2
Antal sider5
ISSN2398-595X
DOI
StatusUdgivet - 2020

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