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 -