LAAO With Amplatzer AmuletPRECISE LAAONCT04640051
Preprocedural Assessment of Anatomy and Device Sizing With CT and 3D Simulation in Left Atrial Appendage Occlusion.
An observational study of LAAO With Amplatzer Amulet, run by AZ Sint-Jan AV at 6 sites in Belgium.
Trial summary
The objectives of the current proposal are to analyse to what extend: 1. The use of 3D in silico simulation by FEops HEARTguide improves of influences the pre-procedural assessment and device size selection and to what extend it correlates with final implanted device size and depth compared to TEE, CT and angiography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- LAAO With Amplatzer Amulet
- What is being tested?
- LAAO
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 6 sitesBelgium
- Study dates
- 2 Jul 2021to 12 Jan 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 100 consecutive patients, schedule for LAAO with Amplatzer Amulet (Abbott) will be enrolled in this prospective registry after receiving signed informed consent.
Who may be able to join
- Patient signed informed consent
- Patient scheduled for LAAO with Amplatzer Amulet (Abbott)
- 3D in silico simulation by FEops HEARTguide available and reviewed before implantation
Who cannot join
- 3D in silico simulation by FEops HEARTguide not available or not reviewed before implantation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
ZNA Middelheim
Antwerp
AZ Sint-Jan Brugge-Oostende AV
Bruges
UZ Brussel
Brussels
Ziekenhuis Oost-Limburg
Genk
AZ Maria Middelares
Ghent
Sart Tilman - CHU de Liège
Liège
About this study
Official title: Preprocedural Assessment of Anatomy and Device Sizing With CT and 3D Simulation in Left Atrial Appendage Occlusion: the PRECISE LAAO Registry
The objectives of the current proposal are to analyse to what extend:
- The use of 3D in silico simulation by FEops HEARTguide improves of influences the pre-procedural assessment and device size selection and to what extend it correlates with final implanted device size and depth compared to TEE, CT and angiography.
- The use of 3D in silico simulation by FEops HEARTguide increases the operator's confidence in the device size selection.
A total of 100 consecutive patients for the total registry, or 15 to 20 consecutive patients per center, with standard of care follow-up at ±6 weeks and 1 year post procedure.
Read the detailed description
Left atrial appendage (LAA) occlusion (LAAO) is a well-accepted alternative to oral anticoagulant in the prevention of stroke or systemic thromboembolism in patients with atrial fibrillation (AF).1 While the occlusion is effective, the procedure can sometime be challenging. Part of the challenge is based on the high degree of variability, both at the patient level (anatomy, size, access, filling status etc); and at the device level (different architecture, size, depth, degree of conformity or compression of the device etc.). This is reflected in the percentage change in device sizes of 6.1% to 6.4%; inability to close the LAA 1% to 2.7%; complications such as embolization, tamponade etc.; residual leaks and chances for thrombus formation and subsequent stroke or systemic embolization; lengthy procedures etc.2,3 A well-prepared preprocedural planning addressing the exact anatomy of the left atrial appendage in conjunction with the optimal device size and conformability, results in optimal device selection, reduced instrumentation in the left atrium, faster and safer procedure and optimal final occlusion of the LAA. Different and complimentary techniques are being used by implanting teams, such as transoesophageal echocardiography (TEE), computed tomography (CT) scan, angiography, 3D reconstruction and 3D printing etc.
Some centres are using FEops HEARTguideTM as part of their preprocedural assessment. This is a computational tomography (CT)-based 3D in silico simulation technology suite relying on proprietary computational modelling and simulation techniques, offering physicians detailed preoperative insights into the interaction between transcatheter structural heart devices and the patient's anatomy. It is CE-marked and commercially available on the European and Canadian market. It is currently being used in 81 hospitals in 22 countries.
Belgian Hospitals who are using 3D simulations by FEops HEARTguide as part of their preprocedural assessment are asked to participate to this prospective multicentric registry. The present registry aims to compare all preprocedural imaging tools and to investigate to what extend 3D in silico simulations influences device size selection in LAAO.
The objectives of the current proposal are to analyse to what extend:
- The use of 3D in silico simulation by FEops HEARTguide improves of influences the pre-procedural assessment and device size selection and to what extend it correlates with final implanted device size and depth compared to TEE, CT and angiography.
- The use of 3D in silico simulation by FEops HEARTguide increases the operator's confidence in the device size selection.
A total of 100 consecutive patients for the total registry, or 15 to 20 consecutive patients per center, with standard of care follow-up at ±6 weeks and 1 year post procedure.
- Conditions
- LAAO With Amplatzer Amulet
- Being tested
- LAAO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAAOProcedure or surgery
LAAO by use of 3D in silico simulation by FEops HEARTguide as part of the pre-procedural assessment and device size selection
| Study group | Role | What they receive |
|---|---|---|
| LAAO group | Patients scheduled for LAAO with Amplatzer Amulet (Abbott) and for whom a 3D in silico simulation by FEops HEARTguide is available and reviewed before implantation Receives: Procedure: LAAO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pre-procedural device size selection by use of FEops HEARTguide
Correlation between device size selection by use of FEops HEARTguide and implanted device size
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start2 Jul 2021
- Primary completion22 Apr 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LAAO With Amplatzer AmuletStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Buysschaert, MD PhD, AZ Sint-Jan AV
- Investigators
- Ian Buysschaert, MD, PhD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640051
- Sponsor's protocol ID
- version 1.0 26/10/2020
- Acronym
- PRECISE LAAO
- Status last verified
- Mar 2024
- First submitted
- 17 Nov 2020
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Cock E, Lochy S, Rivero-Ayerza M, Lempereur M, Cornelis K, Debonnaire P, Vermeersch P, Christiaen E, Buysschaert I. Clinical Value of CT-Based 3D Computational Modeling in Left Atrial Appendage Occlusion: An In-Depth Analysis of the PRECISE LAAO Study. Catheter Cardiovasc Interv. 2025 May;105(6):1356-1364. doi: 10.1002/ccd.31464. Epub 2025 Feb 24.
PubMed 39989438Swaans 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 34412800
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preprocedural Assessment of Anatomy and Device Sizing With CT and 3D Simulation in Left Atrial Appendage Occlusion: the PRECISE LAAO Registry
- ClinicalTrials.gov ID
- NCT04640051
- Acronym / sponsor ID
- PRECISE LAAO / version 1.0 26/10/2020
- Conditions
- LAAO With Amplatzer Amulet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 22 Apr 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 23 Nov 2020 (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.
The objectives of the current proposal are to analyse to what extend:
- The use of 3D in silico simulation by FEops HEARTguide improves of influences the pre-procedural assessment and device size selection and to what extend it correlates with final implanted device size and depth compared to TEE, CT and angiography.
- The use of 3D in silico simulation by FEops HEARTguide increases the operator's confidence in the device size selection.
A total of 100 consecutive patients for the total registry, or 15 to 20 consecutive patients per center, with standard of care follow-up at ±6 weeks and 1 year post procedure.
Detailed description
Left atrial appendage (LAA) occlusion (LAAO) is a well-accepted alternative to oral anticoagulant in the prevention of stroke or systemic thromboembolism in patients with atrial fibrillation (AF).1 While the occlusion is effective, the procedure can sometime be challenging. Part of the challenge is based on the high degree of variability, both at the patient level (anatomy, size, access, filling status etc); and at the device level (different architecture, size, depth, degree of conformity or compression of the device etc.). This is reflected in the percentage change in device sizes of 6.1% to 6.4%; inability to close the LAA 1% to 2.7%; complications such as embolization, tamponade etc.; residual leaks and chances for thrombus formation and subsequent stroke or systemic embolization; lengthy procedures etc.2,3 A well-prepared preprocedural planning addressing the exact anatomy of the left atrial appendage in conjunction with the optimal device size and conformability, results in optimal device selection, reduced instrumentation in the left atrium, faster and safer procedure and optimal final occlusion of the LAA. Different and complimentary techniques are being used by implanting teams, such as transoesophageal echocardiography (TEE), computed tomography (CT) scan, angiography, 3D reconstruction and 3D printing etc.
Some centres are using FEops HEARTguideTM as part of their preprocedural assessment. This is a computational tomography (CT)-based 3D in silico simulation technology suite relying on proprietary computational modelling and simulation techniques, offering physicians detailed preoperative insights into the interaction between transcatheter structural heart devices and the patient's anatomy. It is CE-marked and commercially available on the European and Canadian market. It is currently being used in 81 hospitals in 22 countries.
Belgian Hospitals who are using 3D simulations by FEops HEARTguide as part of their preprocedural assessment are asked to participate to this prospective multicentric registry. The present registry aims to compare all preprocedural imaging tools and to investigate to what extend 3D in silico simulations influences device size selection in LAAO.
The objectives of the current proposal are to analyse to what extend:
- The use of 3D in silico simulation by FEops HEARTguide improves of influences the pre-procedural assessment and device size selection and to what extend it correlates with final implanted device size and depth compared to TEE, CT and angiography.
- The use of 3D in silico simulation by FEops HEARTguide increases the operator's confidence in the device size selection.
A total of 100 consecutive patients for the total registry, or 15 to 20 consecutive patients per center, with standard of care follow-up at ±6 weeks and 1 year post procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAAO group | – | Procedure: LAAOPatients scheduled for LAAO with Amplatzer Amulet (Abbott) and for whom a 3D in silico simulation by FEops HEARTguide is available and reviewed before implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 100 consecutive patients, schedule for LAAO with Amplatzer Amulet (Abbott) will be enrolled in this prospective registry after receiving signed informed consent.
Key inclusion criteria (3 listed)
- Patient signed informed consent
- Patient scheduled for LAAO with Amplatzer Amulet (Abbott)
- 3D in silico simulation by FEops HEARTguide available and reviewed before implantation
Key exclusion criteria (1 listed)
- 3D in silico simulation by FEops HEARTguide not available or not reviewed before implantation
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 |
|---|---|---|
| LAAOLAAO by use of 3D in silico simulation by FEops HEARTguide as part of the pre-procedural assessment and device size selection | Procedure or surgery | LAAO group |
Primary outcome
Improvement in pre-procedural device size selection by use of FEops HEARTguide
Time frame: At time of procedure
Correlation between device size selection by use of FEops HEARTguide and implanted device size
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 39989438De Cock E, Lochy S, Rivero-Ayerza M, Lempereur M, Cornelis K, Debonnaire P, Vermeersch P, Christiaen E, Buysschaert I. Clinical Value of CT-Based 3D Computational Modeling in Left Atrial Appendage Occlusion: An In-Depth Analysis of the PRECISE LAAO Study. Catheter Cardiovasc Interv. 2025 May;105(6):1356-1364. doi: 10.1002/ccd.31464. Epub 2025 Feb 24.
- 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.
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.
Ian Buysschaert, MD, PhD principal investigator
AZ Sint-Jan AV
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LAAO With Amplatzer Amulet, run by AZ Sint-Jan AV at 6 sites in Belgium.
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 1 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: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in pre-procedural device size selection by use of FEops HEARTguide (time frame: At time of procedure). 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 NCT04640051, which also lists 2 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 8 Mar 2024.