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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
  1. Philippe Garot1,
  2. Xavier Iriart2,
  3. Adel Aminian3,
  4. Joelle Kefer4,
  5. Xavier Freixa5,
  6. Ignacio Cruz-Gonzalez6,
  7. Sergio Berti7,
  8. Liesbeth Rosseel8,
  9. Reda Ibrahim9,
  10. Kasper Korsholm10,
  11. Jacob Odenstedt11,
  12. Jens-Erik Nielsen-Kudsk10,
  13. Jaqueline Saw12,
  14. Lars Sondergaard13 and
  15. Ole De Backer13
  1. 1Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, Île-de-France, France
  2. 2Pediatric and Congenital Cardiology, University Hospital of Bordeaux, Pessac, MS, France
  3. 3Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Hainaut, Belgium
  4. 4Division of Cardiology, Cliniques Universitaires Saint-Luc, Brussels, Belgium
  5. 5Cardiovascular Institute, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain
  6. 6Department of Cardiology, Hospital Clínico Universitario de Salamanca, Salamanca, Spain
  7. 7Cardiology Unit, Fondazione CNR Regione Toscana, Massa, Italy
  8. 8Department of Cardiology, University Hospital Galway, Galway, Ireland
  9. 9Department of Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada
  10. 10Department of Cardiology, Aarhus Universitetshospital Skejby, Aarhus, Denmark
  11. 11Department of Cardiology, Sahlgrenska University Hospital, Goteborg, Sweden
  12. 12Department of Cardiology, Vancouver General Hospital, Vancouver, British Columbia, Canada
  13. 13Department of Cardiology, Rigshospitalet, Copenhagen, Denmark
  1. Correspondence to Dr Ole De Backer; ole.debacker{at}gmail.com

Abstract

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).

  • atrial fibrillation
  • stroke
  • device closure
  • CT scanning
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors PG and ODB designed the study and prepared the first draft of the manuscript. XI, AA, JK, XF, ICG, SB, LR, RI, KK, JO, JENK, JS and LS contributed to manuscript revision. All authors will contribute to enrolment and patient treatment in the study.

  • Funding The study is funded by Abbott (Minneapolis, MN, USA) and FEops NV (Ghent, Belgium).

  • Competing interests ODB and LS have received institutional research grants from Abbott and FEops NV.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data may be obtained from a third party and are not publicly available. This is a study protocol, not containing study results/data yet.

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