Computational Simulation to Plan for Percutaneous Left Atrial Appendage Closure

NCT04180605 | Unknown

• 1 other identifier: H-19043746 - PREDICT-LAA
• Study Type: interventional
• Target: 200
• Locations: 7 countries
• Sites: 12

Brief 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.

Conditions

Atrial Fibrillation; Stroke Prevention

Keywords

Atrial fibrillation; Left atrial appendage; Transcatheter closure; Stroke prevention; Computed tomography; Computational simulation; Preoperative planning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of closure devices used

  Periprocedural

• Number of repositioning

  Periprocedural

• Procedural time

  Periprocedural

• Radiation exposure

  Periprocedural

• Contrast medium

  Periprocedural

Study Arms (2)

Standard of care treatment arm

ACTIVE COMPARATOR

When patients are randomized to the standard treatment arm, patients will be treated according to the participating site's routine practice. As pre-procedural imaging, a cardiac CT-scan has to be performed; this can also be complemented with TEE at the discretion of the operator. The LAA closure procedure should be performed according to routine practice of the participating site - either in general or local anesthesia. For those cases randomized to the standard treatment arm, the pre-procedural CT-scans will still be collected at completion of the study and FEops HEARTguideTM simulations will be generated, blinded for the procedural images and outcome. These simulations will be compared with the final device size and implant position and will be used for an additional comparative PREDICT-LAA sub-study.

Procedure: Left atrial appendage closure

Computational simulation arm

EXPERIMENTAL

When patients are randomized to the computational simulation arm, the procedure will still be performed according to the participating site's routine practice - however, the procedure will only be performed after careful review of the FEops HEARTguideTM simulation results. The only prerequisite is that all patients randomized to this arm will have to undergo a pre-procedural cardiac CT-scan that will be uploaded into the FEops HEARTguideTM platform. Following this upload, a pre-procedural simulation plan will be provided to the operator, containing a set of optimal and suboptimal closure device sizes and implant positions. Software and technology upgrades of the FEops HEARTguideTM platform will be allowed during the course of the study.

Other: Additional support for preoperative planning of LAA closure procedures; Procedure: Left atrial appendage closure

Interventions

Additional support for preoperative planning of LAA closure procedures OTHER

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.

Computational simulation arm

Left atrial appendage closure PROCEDURE

Transcatheter device insertion to exclude the LAA from the cardiac circulation

Computational simulation arm; Standard of care treatment arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Feops: collaborator
• Abbott: collaborator

Study Sites (12)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

NOT YET RECRUITING

Hopital Civil Marie Curie CHU de Charleroi

Charleroi, 6042, Belgium

NOT YET RECRUITING

Montreal Heart Institute

Montreal, QC H1T 1C8, Canada

NOT YET RECRUITING

Vancouver General Hospital

Vancouver, BC V5Z 1M9, Canada

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33600, France

NOT YET RECRUITING

Institut Cardiovasculaire Paris Sud

Massy, 91300, France

NOT YET RECRUITING

Fondazione Toscana G. Monasterio

Massa, 54100, Italy

NOT YET RECRUITING

Hospital Clinic Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

NOT YET RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

NOT YET RECRUITING

Related Publications (10)

• 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.

  PMID: 25399274 BACKGROUND

• Chow DH, Bieliauskas G, Sawaya FJ, Millan-Iturbe O, Kofoed KF, Sondergaard 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.

  PMID: 28761682 BACKGROUND

• 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.

  PMID: 28866042 BACKGROUND

• 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. No abstract available.

  PMID: 26088522 BACKGROUND

• 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.

  PMID: 30846521 BACKGROUND

• 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.

  PMID: 29386188 BACKGROUND

• Bavo AM, Wilkins BT, Garot P, De Bock S, Saw J, Sondergaard 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. 2020 Mar-Apr;14(2):149-154. doi: 10.1016/j.jcct.2019.08.010. Epub 2019 Aug 20.

  PMID: 31445885 BACKGROUND

• De Backer O, Iriart X, Kefer J, Nielsen-Kudsk JE, Aminian A, Rosseel L, Kofoed KF, Odenstedt J, Berti S, Saw J, Sondergaard L, Garot P. Impact of Computational Modeling on Transcatheter Left Atrial Appendage Closure Efficiency and Outcomes. JACC Cardiovasc Interv. 2023 Mar 27;16(6):655-666. doi: 10.1016/j.jcin.2023.01.008. Epub 2023 Feb 22.

  PMID: 36990554 DERIVED

• Swaans MJ, Huijboom MFM, Boersma LVA. Fluoroscopic Guidance: An Echo From the Past? JACC Cardiovasc Interv. 2021 Aug 23;14(16):1827-1829. doi: 10.1016/j.jcin.2021.07.003. No abstract available.

  PMID: 34412800 DERIVED

• Garot P, Iriart X, Aminian A, Kefer J, Freixa X, Cruz-Gonzalez I, Berti S, Rosseel L, Ibrahim R, Korsholm K, Odenstedt J, Nielsen-Kudsk JE, Saw J, Sondergaard L, De Backer O. Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study. Open Heart. 2020 Aug;7(2):e001326. doi: 10.1136/openhrt-2020-001326.

  PMID: 32763967 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Ole De Backer, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole De Backer, MD PhD

CONTACT

+45-35457086; ole.debacker@gmail.com

Marie-Louise Mahler Sørensen

CONTACT

Marie.Louise.Mahler.Soerensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ole De Backer, MD, PhD, Consultant Interventional Cardiology

Model Details: 200 patients selected for percutaneous LAA closure with an AmplatzerTM AmuletTM device will be enrolled in this study and randomized into the following two arms: the comparator (standard of care arm) for whom the procedure will be conducted following the standard of care of the center, and the computational simulation arm where the pre-procedural planning will include a careful analysis of the computational simulation results provided by the FEops HEARTguideTM platform.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 27, 2019
• Study Start: January 6, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); BE (2); DK (2); IT (1); CA (2); FR (2); ES (2)