To prevent stroke in patients with non-valvular atrial fibrillation (NVAF) and
contraindication(s) to oral anticoagulant therapy, percutaneous left atrial appendage (LAA)
closure is increasily being chosen as an alternative therapeutic option. To obtain a
successful percutaneous LAA closure, an accurate preoperative planning is required to
understand the LAA morphology and assess the correct size and optimal position of the device.
The instructions for use (IFUs) of the medical device providers are still based on
two-dimensional transesophageal echocardiography, whereas an increasing number of centers
have shifted towards LAA sizing and planning based on cardiac computed tomography (CT)
images. Other options are also available for preoperative planning, among others the use of
3D printed LAA models. However, this has a number of disadvantages, among others complex
logistics and the possible inaccuracy in terms of mechanical response of the printing
material used for the 3D printed model.
Based on the FEops HEARTguideTM platform, a computational model for percutaneous LAA closure
was developed and validated. The computer simulations are based on CT images, and can predict
different possible LAA closure options for the patient, including optimal and suboptimal
sizing and positioning of the LAA closure device. This can be achieved by modelling the
mechanical interaction between the device and the 3D patient-specific LAA anatomy
reconstructed from the CT images. The results are available as a web-based 3D-viewer and
allow the physician to analyse the different device size and implant position options prior
to the procedure.
The PREDICT-LAA trial aims to study the possible added value of FEops HEARTguideTM
patient-specific computational simulation in the planning of percutaneous LAA closure with
the AmplatzerTM AmuletTM device, with special focus on procedural safety and efficiency as
well as on clinical outcomes.
The PREDICT-LAA study is a prospective, multicenter, randomized controlled trial. In total,
200 patients eligible for percutaneous LAA closure with an AmplatzerTM AmuletTM device
(Abbott, USA) will be enrolled - 100 patients will be allocated to the computational
simulation treatment arm and 100 patients to the standard treatment arm.
All participants will be treated according to the standard of care of the center -
additionally, the preoperative planning for patients allocated to the computational
simulation treatment arm will include a careful analysis of the computational simulation
results provided by the FEops HEARTguideTM platform.
Patients with non-valvular atrial fibrillation who are referred to and deemed eligible for
percutaneous LAA closure with an AmplatzerTM AmuletTM closure device can be included.
Patients with reduced renal function, known contrast agent allergy, and/or suboptimal cardiac
CT-image quality are excluded from this trial.
The participant shall be informed about the aim and procedure of the PREDICT-LAA study and
written informed consent shall be obtained in order to include the participant.
All patients enrolled in the PREDICT-LAA study should have a post-procedural cardiac CT scan
at three months after the LAA closure procedure to check for complete LAA closure,
device-related thrombosis (DRT) and device position. The CT CoreLab for assessment of this
post-procedural CT-scans will be performed at Rigshospitalet, Copenhagen, Denmark. The
readers of the CT-scan will be blinded from the baseline data, randomisation arm and
procedural data.
The risk related to this study and, in particular, the CT-scan is low - especially as
patients with renal insufficiency, iodine contrast allergy and/or contraindications for
CT-scan are excluded. Concerning the radiation dose of maximally two CT-scans, we can report
that patients will receive a radiation dose of 6 to 15 mSievert, depending on weight and
heart frequency/rhythym. It can be calculated that lifetime risk to die from cancer, hereby,
theoretically increases with maximally 0,06%. Thus, the patients' lifetime risk to die from
cancer increases from 25.0% to 25.06%.
The patients are informed about the aim and procedure of the study and are only included in
case of written consent. Unknown side effects or risks associated with the study cannot be
ruled-out.
The protocol of the trial has been approved by local regional Ethics Committees in each
participating country, the collection of data complies with the regulatory rules of the
Danish Data Protection Agency, and the study is being conducted in compliance with good
clinical practice and with the Helsinki II Declaration as adopted by the 18th World Medical
Assembly in Helsinki, Finland, in 1964 and subsequent versions.