TY - JOUR T1 - 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 JF - Open Heart JO - Open Heart DO - 10.1136/openhrt-2020-001326 VL - 7 IS - 2 SP - e001326 AU - Philippe Garot AU - Xavier Iriart AU - Adel Aminian AU - Joelle Kefer AU - Xavier Freixa AU - Ignacio Cruz-Gonzalez AU - Sergio Berti AU - Liesbeth Rosseel AU - Reda Ibrahim AU - Kasper Korsholm AU - Jacob Odenstedt AU - Jens-Erik Nielsen-Kudsk AU - Jaqueline Saw AU - Lars Sondergaard AU - Ole De Backer Y1 - 2020/08/01 UR - http://openheart.bmj.com/content/7/2/e001326.abstract N2 - 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). ER -