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
- device closure
- CT scanning
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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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