Computational Simulation to Plan for Percutaneous Left Atrial Appendage Closure

Atrial Fibrillation Clinical Trial

Official title:

The Value of FEops HEARTguideTM Patient-Specific Computational Simulation in the Planning of Percutaneous Left Atrial Appendage Closure With the AmplatzerTM AmuletTM Device (PREDICT-LAA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180605
• Other study ID #: H-19043746 - PREDICT-LAA
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 2022

Study information

• Verified date: April 2020
• Source: Rigshospitalet, Denmark
• Contact: Ole De Backer, MD PhD
• Phone: +45-35457086
• Email: ole.debacker[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To ensure a successful percutaneous left atrial appendage (LAA) closure, it is important to select the correct size of the closure device used for each patient. To define and measure the size of the LAA, 2D transesophageal echocardiography (TEE) has been typically used. An increasing number of hospitals recently switched to measure the size of the LAA using a cardiac computed tomography (CT) scan. Although this CT scan helps to better define and measure the LAA, it is still difficult to determine the exact anticipated 'landing zone' or 'position' of the closure device. A novel strategy of preprocedural planning includes the use of preoperative computer simulations based on CT imaging (Feops HEARTguideTM), where the device is deployed with a computer simulation into the patient-specific LAA anatomy to provide the operator both optimal and suboptimal scenario's showing different sizes and positions of the closure device.

The aim of this study is to assess whether use of FEops HEARTguide computer simulations based on cardiac CT-imaging can contribute to a better preprocedural planning and improved procedural outcomes of percutaneous LAA closure procedures with an Amplatzer Amulet device.

The PREDICT-LAA trial will investigate the possible positive effect of a computer simulation using a CT scan of the LAA performed prior to the procedure. The hypothesis is that by using this new computer simulation, better planning of the intervention can be obtained.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age above 18 years.

• Patients with non-valvular atrial fibrillation (NVAF) who are referred to and approved for percutaneous LAA closure with an Amplatzer Amulet closure device, according to local practice and legislation.

• Written informed consent.

Exclusion Criteria:

• Reduced renal function with eGFR < 30 mL/min/1.73 m^2.

• Iodine contrast allergy or other condition that prohibits cardiac CT imaging.

• Suboptimal image quality of the pre-procedural cardiac CT-scan.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke Prevention

Intervention

Other:
• Additional support for preoperative planning of LAA closure procedures
The results of the computational simulations provided by FEops HEARTguideTM will be used in the "computational simulation arm" as an additional preoperative planning tool and their potential added value will be assessed by comparison to the standard of care arm.

Procedure:
• Left atrial appendage closure
Transcatheter device insertion to exclude the LAA from the cardiac circulation

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Hopital Civil Marie Curie CHU de Charleroi	Charleroi
Canada	Montreal Heart Institute	Montréal
Canada	Vancouver General Hospital	Vancouver
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Institut Cardiovasculaire Paris Sud	Massy
Italy	Fondazione Toscana G. Monasterio	Massa
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Universitario de Salamanca	Salamanca
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Abbott, feops

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  France,  Italy,  Spain,  Sweden, 

References & Publications (7)

Bavo AM, Wilkins BT, Garot P, De Bock S, Saw J, Søndergaard L, De Backer O, Iannaccone F. Validation of a computational model aiming to optimize preprocedural planning in percutaneous left atrial appendage closure. J Cardiovasc Comput Tomogr. 2019 Aug 20. pii: S1934-5925(19)30196-0. doi: 10.1016/j.jcct.2019.08.010. [Epub ahead of print] — View Citation

Chow DH, Bieliauskas G, Sawaya FJ, Millan-Iturbe O, Kofoed KF, Søndergaard L, De Backer O. A comparative study of different imaging modalities for successful percutaneous left atrial appendage closure. Open Heart. 2017 Jun 30;4(2):e000627. doi: 10.1136/openhrt-2017-000627. eCollection 2017. — View Citation

de Jaegere P, Rocatello G, Prendergast BD, de Backer O, Van Mieghem NM, Rajani R. Patient-specific computer simulation for transcatheter cardiac interventions: what a clinician needs to know. Heart. 2019 Mar;105(Suppl 2):s21-s27. doi: 10.1136/heartjnl-2018-313514. Review. — View Citation

Korsholm K, Jensen JM, Nielsen-Kudsk JE. Intracardiac Echocardiography From the Left Atrium for Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion. JACC Cardiovasc Interv. 2017 Nov 13;10(21):2198-2206. doi: 10.1016/j.jcin.2017.06.057. Epub 2017 Aug 30. — View Citation

Otton JM, Spina R, Sulas R, Subbiah RN, Jacobs N, Muller DW, Gunalingam B. Left Atrial Appendage Closure Guided by Personalized 3D-Printed Cardiac Reconstruction. JACC Cardiovasc Interv. 2015 Jun;8(7):1004-6. doi: 10.1016/j.jcin.2015.03.015. — View Citation

Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum in: JAMA. 2015 Mar 10;313(10):1061. — View Citation

Rocatello G, El Faquir N, De Santis G, Iannaccone F, Bosmans J, De Backer O, Sondergaard L, Segers P, De Beule M, de Jaegere P, Mortier P. Patient-Specific Computer Simulation to Elucidate the Role of Contact Pressure in the Development of New Conduction Abnormalities After Catheter-Based Implantation of a Self-Expanding Aortic Valve. Circ Cardiovasc Interv. 2018 Feb;11(2):e005344. doi: 10.1161/CIRCINTERVENTIONS.117.005344. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incomplete LAA closure and definite device-related thrombosis (DRT)	The percentage of patients with incomplete LAA closure (defined as any remaining contrast leakage into the LAA distal of the Amulet lobe) and/or a definite DRT at post-procedural cardiac CT imaging at three months after the procedure. Definite DRT is defined as "high-grade" hypo-attenuating thickening at the atrial surface of the closure device - as previously described by Korsholm et al., Circ Cardiovasc Interv, 2019.	Post-procedural cardiac CT scan at 3 months after LAA closure
Secondary	Number of closure devices used	Number of LAA closure devices used per procedure	Periprocedural
Secondary	Number of repositioning	Number of LAA closure device repositionings per procedure. Repositioning is defined as full deployment of the Amulet lobe in the LAA, followed by either a full or partial recapture and re-deployment of the Amulet lobe	Periprocedural
Secondary	Procedural time	Duration of the LAA closure procedure [minutes]	Periprocedural
Secondary	Radiation exposure	Radiation exposure per procedure [Gy]	Periprocedural
Secondary	Contrast medium	Amount of contrast medium used per procedure [mL]	Periprocedural
Secondary	Procedural-related complications	Recording of the following events if any: LAA closure device embolization; Pericardial effusion requiring intervention; Procedure-related stroke; Procedure-related death	Periprocedural and between randomization and within 7 days of the procedure
Secondary	Final position of the device	Coverage of all LAA trabeculations by the Amulet shaped disc of the Amulet lobe/disc and a concave device without retraction of the disc into the LAA	During post-procedural cardiac CT scan at 3 months after LAA closure
Secondary	Composite of all-cause death and thromboembolic event	Recording of the following events if any: transient ischemic attack, ischemic stroke, systemic embolism	12 months after randomization
Secondary	Different degrees of contrast leakage into the LAA	Different degrees of contrast leakage into the LAA	Post-procedural cardiac CT scan at 3 months after LAA closure