Atrial FibrillationNCT04180605
Computational Simulation to Plan for Percutaneous Left Atrial Appendage Closure
A study testing Additional support for preoperative planning of LAA closure procedures and Left atrial appendage closure in people with Atrial Fibrillation and Stroke Prevention, run by Copenhagen University Hospital, Rigshospitalet at 12 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Stroke Prevention
- What is being tested?
- Additional support for preoperative planning of LAA closure procedures and Left atrial appendage closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 6 Jan 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 7 countries.
Marie-Louise Mahler Sørensen contact
12 sites in 7 countries
Belgium2 sites, 2 recruiting
- Not yet recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
Joelle Kefer, joelle.kefer@uclouvain.be
- Not yet recruiting
Hopital Civil Marie Curie CHU de Charleroi
Charleroi, 6042
Adel Aminian, adel.aminian@chu-charleroi.be
Canada2 sites, 2 recruiting
- Not yet recruiting
Montreal Heart Institute
Montreal, QC H1T 1C8
Ibrahim Reda, reda.ibrahim@icm-mhi.org
- Not yet recruiting
Vancouver General Hospital
Vancouver, BC V5Z 1M9
Jacqueline Saw, +1-8805788, jsaw@mail.ubc.ca
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Jens-Erik Nielsen-Kudsk, +45-30922341, je.nielsen.kudsk@gmail.com
- Recruiting
Rigshospitalet
Copenhagen, 2100
Ole De Backer, MD, PhD, +45-35457086, ole.debacker@gmail.com
France2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33600
Xavier Iriart, +33-622323745, xavier.iriart@chu-bordeaux.fr
- Not yet recruiting
Institut Cardiovasculaire Paris Sud
Massy, 91300
Philippe Garot, +33-160134602, pgarot@angio-icps.com
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Clinic Barcelona
Barcelona, 08036
Xavier Freixa, +34 93 451 87 46, freixa@clinic.cat
- Not yet recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
Ignatio Cruz, +34-687425695, cruzgonzalez.ignacio@gmail.com
Italy1 site, 1 recruiting
- Not yet recruiting
Fondazione Toscana G. Monasterio
Massa, 54100
Sergio Berti, +39 348 896 4831, sergio.berti@ftgm.it
Sweden1 site, 1 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Jacob Odenstedt, jacob.odenstedt@vgregion.se
About this study
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)
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation, Stroke Prevention
- Being tested
- Additional support for preoperative planning of LAA closure procedures, Left atrial appendage closure
- Keywords
- Atrial fibrillation, Left atrial appendage, Transcatheter closure, Stroke prevention, Computed tomography, Computational simulation, Preoperative planning
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional support for preoperative planning of LAA closure proceduresOther
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.
Left atrial appendage closureProcedure or surgery
Transcatheter device insertion to exclude the LAA from the cardiac circulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Additional support for preoperative planning of LAA closure procedures; Procedure: Left atrial appendage closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-procedural cardiac CT scan at 3 months after LAA closure
Secondary outcomes (9)
Number of closure devices used
Number of LAA closure devices used per procedure
Measured: Periprocedural
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
Measured: Periprocedural
Procedural time
Duration of the LAA closure procedure [minutes]
Measured: Periprocedural
Radiation exposure
Radiation exposure per procedure [Gy]
Measured: Periprocedural
Contrast medium
Amount of contrast medium used per procedure [mL]
Measured: Periprocedural
Procedural-related complications
Recording of the following events if any:
- LAA closure device embolization
- Pericardial effusion requiring intervention
- Procedure-related stroke
- Procedure-related death
Measured: Periprocedural and between randomization and within 7 days of the procedure
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
Measured: During post-procedural cardiac CT scan at 3 months after LAA closure
Composite of all-cause death and thromboembolic event
Recording of the following events if any: transient ischemic attack, ischemic stroke, systemic embolism
Measured: 12 months after randomization
Different degrees of contrast leakage into the LAA
Different degrees of contrast leakage into the LAA
Measured: Post-procedural cardiac CT scan at 3 months after LAA closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start6 Jan 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Feops, Abbott
- Responsible party
- Principal investigator, Ole De Backer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ole De Backer, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180605
- Sponsor's protocol ID
- H-19043746 - PREDICT-LAA
- Status last verified
- Apr 2020
- First submitted
- 21 Nov 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25399274Chow 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.
PubMed 28761682Korsholm 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.
PubMed 28866042Otton 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.
PubMed 26088522de 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.
PubMed 30846521Rocatello 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.
PubMed 29386188Bavo 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.
PubMed 31445885De 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.
PubMed 36990554Swaans 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.
PubMed 34412800Garot 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.
PubMed 32763967
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04180605
- Acronym / sponsor ID
- H-19043746 - PREDICT-LAA
- Conditions
- Atrial Fibrillation, Stroke Prevention
- Keywords
- Atrial fibrillation, Left atrial appendage, Transcatheter closure, Stroke prevention, Computed tomography, Computational simulation, Preoperative planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Feops, Abbott
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of care treatment arm | Active comparator | Procedure: Left atrial appendage closureWhen 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. |
| Computational simulation arm | Experimental | Other: Additional support for preoperative planning of LAA closure procedures, Procedure: Left atrial appendage closureWhen 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional support for preoperative planning of LAA closure proceduresThe 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. | Other | Computational simulation arm |
| Left atrial appendage closureTranscatheter device insertion to exclude the LAA from the cardiac circulation | Procedure or surgery | Computational simulation arm, Standard of care treatment arm |
Primary outcome
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.
9 secondary outcomes
Number of closure devices used
Time frame: Periprocedural
Number of repositioning
Time frame: Periprocedural
Procedural time
Time frame: Periprocedural
Radiation exposure
Time frame: Periprocedural
Contrast medium
Time frame: Periprocedural
Procedural-related complications
Time frame: Periprocedural and between randomization and within 7 days of the procedure
Final position of the device
Time frame: During post-procedural cardiac CT scan at 3 months after LAA closure
Composite of all-cause death and thromboembolic event
Time frame: 12 months after randomization
Different degrees of contrast leakage into the LAA
Time frame: Post-procedural cardiac CT scan at 3 months after LAA closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 25399274Reddy 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.
- Background: PubMed 28761682Chow 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.
- Background: PubMed 28866042Korsholm 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.
- Background: PubMed 26088522Otton 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.
- Background: PubMed 30846521de 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.
- Background: PubMed 29386188Rocatello 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.
- Background: PubMed 31445885Bavo 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.
- Derived from this study: PubMed 36990554De 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.
- Derived from this study: PubMed 34412800Swaans 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.
- Derived from this study: PubMed 32763967Garot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Louise Mahler Sørensen contact
Ole De Backer, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional support for preoperative planning of LAA closure procedures and Left atrial appendage closure in people with Atrial Fibrillation and Stroke Prevention, run by Copenhagen University Hospital, Rigshospitalet at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Canada, Denmark, France, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ole De Backer, MD PhD (+45-35457086, ole.debacker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incomplete LAA closure and definite device-related thrombosis (DRT) (time frame: Post-procedural cardiac CT scan at 3 months after LAA closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180605, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.