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Computational Simulation to Plan for Percutaneous Left Atrial Appendage Closure

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ClinicalTrials.gov Identifier: NCT04180605
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
feops
Abbott
Information provided by (Responsible Party):
Ole De Backer, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Prevention Other: Additional support for preoperative planning of LAA closure procedures Procedure: Left atrial appendage closure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : January 6, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of care treatment arm

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
Transcatheter device insertion to exclude the LAA from the cardiac circulation

Experimental: Computational simulation arm
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
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




Primary Outcome Measures :
  1. Incomplete LAA closure and definite device-related thrombosis (DRT) [ Time Frame: Post-procedural cardiac CT scan at 3 months after LAA closure ]
    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.


Secondary Outcome Measures :
  1. Number of closure devices used [ Time Frame: Periprocedural ]
    Number of LAA closure devices used per procedure

  2. Number of repositioning [ Time Frame: Periprocedural ]
    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

  3. Procedural time [ Time Frame: Periprocedural ]
    Duration of the LAA closure procedure [minutes]

  4. Radiation exposure [ Time Frame: Periprocedural ]
    Radiation exposure per procedure [Gy]

  5. Contrast medium [ Time Frame: Periprocedural ]
    Amount of contrast medium used per procedure [mL]

  6. Procedural-related complications [ Time Frame: Periprocedural and between randomization and within 7 days of the procedure ]

    Recording of the following events if any:

    • LAA closure device embolization
    • Pericardial effusion requiring intervention
    • Procedure-related stroke
    • Procedure-related death

  7. Final position of the device [ Time Frame: During post-procedural cardiac CT scan at 3 months after LAA closure ]
    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

  8. Composite of all-cause death and thromboembolic event [ Time Frame: 12 months after randomization ]
    Recording of the following events if any: transient ischemic attack, ischemic stroke, systemic embolism

  9. Different degrees of contrast leakage into the LAA [ Time Frame: Post-procedural cardiac CT scan at 3 months after LAA closure ]
    Different degrees of contrast leakage into the LAA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180605


Contacts
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Contact: Ole De Backer, MD PhD +45-35457086 ole.debacker@gmail.com
Contact: Marie-Louise Mahler Sørensen Marie.Louise.Mahler.Soerensen@regionh.dk

Locations
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Belgium
Cliniques Universitaires Saint Luc Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Joelle Kefer       joelle.kefer@uclouvain.be   
Hopital Civil Marie Curie CHU de Charleroi Not yet recruiting
Charleroi, Belgium, 6042
Contact: Adel Aminian       adel.aminian@chu-charleroi.be   
Canada
Montreal Heart Institute Not yet recruiting
Montréal, Canada, QC H1T 1C8
Contact: Ibrahim Reda       reda.ibrahim@icm-mhi.org   
Vancouver General Hospital Not yet recruiting
Vancouver, Canada, BC V5Z 1M9
Contact: Jacqueline Saw    +1-8805788    jsaw@mail.ubc.ca   
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Jens-Erik Nielsen-Kudsk    +45-30922341    je.nielsen.kudsk@gmail.com   
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Ole De Backer, MD, PhD    +45-35457086    ole.debacker@gmail.com   
France
Centre Hospitalier Universitaire de Bordeaux Not yet recruiting
Bordeaux, France, 33600
Contact: Xavier Iriart    +33-622323745    xavier.iriart@chu-bordeaux.fr   
Institut Cardiovasculaire Paris Sud Not yet recruiting
Massy, France, 91300
Contact: Philippe Garot    +33-160134602    pgarot@angio-icps.com   
Italy
Fondazione Toscana G. Monasterio Not yet recruiting
Massa, Italy, 54100
Contact: Sergio Berti    +39 348 896 4831    sergio.berti@ftgm.it   
Spain
Hospital Clinic Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Xavier Freixa    +34 93 451 87 46    freixa@clinic.cat   
Hospital Universitario de Salamanca Not yet recruiting
Salamanca, Spain, 37007
Contact: Ignatio Cruz    +34-687425695    cruzgonzalez.ignacio@gmail.com   
Sweden
Sahlgrenska University Hospital Not yet recruiting
Göteborg, Sweden, 41345
Contact: Jacob Odenstedt    jacob.odenstedt@vgregion.se      
Sponsors and Collaborators
Rigshospitalet, Denmark
feops
Abbott
Investigators
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Principal Investigator: Ole De Backer, MD, PhD Rigshospitalet, Denmark
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ole De Backer, Dr. Ole De Backer, MD, PhD, Consultant Interventional Cardiology, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04180605    
Other Study ID Numbers: H-19043746 - PREDICT-LAA
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ole De Backer, Rigshospitalet, Denmark:
Atrial fibrillation
Left atrial appendage
Transcatheter closure
Stroke prevention
Computed tomography
Computational simulation
Preoperative planning
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes