{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T21:12:18Z","timestamp":1777669938418,"version":"3.51.4"},"reference-count":9,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2020,8,6]],"date-time":"2020-08-06T00:00:00Z","timestamp":1596672000000},"content-version":"unspecified","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001316","name":"Abbott Laboratories","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001316","id-type":"DOI","asserted-by":"publisher"}]},{"name":"FEops NV"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Open Heart"],"accepted":{"date-parts":[[2020,5,27]]},"published-print":{"date-parts":[[2020,8]]},"abstract":"\n Background<\/jats:title>\n Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA).<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n The PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605<\/jats:ext-link>). 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n ClinicalTrials.gov Registry (NCT04180605<\/jats:ext-link>).<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/openhrt-2020-001326","type":"journal-article","created":{"date-parts":[[2020,8,7]],"date-time":"2020-08-07T02:03:39Z","timestamp":1596765819000},"page":"e001326","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":28,"title":["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"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct04180605","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04180605","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Philippe","family":"Garot","sequence":"first","affiliation":[{"name":"Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, \u00cele-de-France, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xavier","family":"Iriart","sequence":"additional","affiliation":[{"name":"Pediatric and Congenital Cardiology, University Hospital of Bordeaux, Pessac, MS, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adel","family":"Aminian","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Hainaut, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joelle","family":"Kefer","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cliniques Universitaires Saint-Luc, Brussels, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xavier","family":"Freixa","sequence":"additional","affiliation":[{"name":"Cardiovascular Institute, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ignacio","family":"Cruz-Gonzalez","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Hospital Cl\u00ednico Universitario de Salamanca, Salamanca, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sergio","family":"Berti","sequence":"additional","affiliation":[{"name":"Cardiology Unit, Fondazione CNR Regione Toscana, Massa, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liesbeth","family":"Rosseel","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Hospital Galway, Galway, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reda","family":"Ibrahim","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Montreal Heart Institute, Montreal, Quebec, 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Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"Sondergaard","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9674-0278","authenticated-orcid":false,"given":"Ole","family":"De Backer","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Rigshospitalet, Copenhagen, 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