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

T2 - rationale and design of the PREDICT-LAA study

AU - Garot, Philippe

AU - Iriart, Xavier

AU - Aminian, Adel

AU - Kefer, Joelle

AU - Freixa, Xavier

AU - Cruz-Gonzalez, Ignacio

AU - Berti, Sergio

AU - Rosseel, Liesbeth

AU - Ibrahim, Reda

AU - Korsholm, Kasper

AU - Odenstedt, Jacob

AU - Nielsen-Kudsk, Jens-Erik

AU - Saw, Jaqueline

AU - Sondergaard, Lars

AU - De Backer, Ole

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2020

Y1 - 2020

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).

AB - 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).

KW - Atrial Appendage/diagnostic imaging

KW - Atrial Fibrillation/diagnostic imaging

KW - Atrial Function, Left

KW - Canada

KW - Cardiac Catheterization/adverse effects

KW - Europe

KW - Heart Rate

KW - Humans

KW - Multicenter Studies as Topic

KW - Patient-Specific Modeling

KW - Predictive Value of Tests

KW - Prospective Studies

KW - Randomized Controlled Trials as Topic

KW - Therapy, Computer-Assisted

KW - Tomography, X-Ray Computed

KW - Treatment Outcome

U2 - 10.1136/openhrt-2020-001326

DO - 10.1136/openhrt-2020-001326

M3 - Journal article

C2 - 32763967

VL - 7

JO - Open Heart

JF - Open Heart

SN - 2398-595X

IS - 2

M1 - e001326

ER -