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NCT04640051: PRECISE LAAO
Preprocedural Assessment of Anatomy and Device Sizing With CT and 3D Simulation in Left Atrial Appendage Occlusion.
trial testing LAAO in LAAO With Amplatzer Amulet in 102 participants. Completed in 12 January 2024.
22 April 2023
Quick facts
| Lead sponsor | AZ Sint-Jan AV |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 102 |
| Start date | 2 July 2021 |
| Primary completion | 22 April 2023 |
| Estimated completion | 12 January 2024 |
| Sites | 6 locations across Belgium |
Drugs / interventions tested
- LAAO
Conditions studied
- LAAO With Amplatzer Amulet — all drugs for LAAO With Amplatzer Amulet →
Sponsor
AZ Sint-Jan AV — full company profile →
Who can join
18 and older, any sex, with LAAO With Amplatzer Amulet. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. 2. 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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical Impact of Preprocedural CT-Based 3D Computational Simulation of Left Atrial Appendage Occlusion with Amulet.
Buysschaert I, Viaene D. · · 2021 · cited 6× · PMID 34385893 · DOI 10.1155/2021/9972228 -
Clinical Value of CT-Based 3D Computational Modeling in Left Atrial Appendage Occlusion: An In-Depth Analysis of the PRECISE LAAO Study.
De Cock E, Lochy S, Rivero-Ayerza M, Lempereur M, et al · · 2025 · cited 2× · PMID 39989438 · DOI 10.1002/ccd.31464 -
Clinical Outcomes of Percutaneous Left-Atrial Appendage Occlusion with Conscious Sedation without an Anesthesiologist on Site: Results from a Multicenter Study
Bianco M, Visalli A, Tomassini F, Biolè C, et al · · 2023
Verify or expand the search:
- PubMed search for NCT04640051
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LAAO
Trials testing the same drug.
- NCT06212674 — Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients · Phase 4 · recruiting
- NCT03088098 — Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in AF Undergoing TAVI · NA · completed
Other AZ Sint-Jan AV trials
Trials by the same sponsor.
- NCT07501481 — Arrhythmic Risk in Myocarditis Outcome Research · not yet recruiting
- NCT04784039 — D-Dimer-based Indication for Transesophageal Echocardiography to Exclude Left Atrial Thrombus Before Cardioversion of No · Phase 4 · unknown
- NCT06095765 — Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention · Phase 3 · recruiting
- NCT05577078 — TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Rep · not yet recruiting
- NCT05365568 — Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04640051 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AZ Sint-Jan AV
- Last refreshed: 8 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04640051.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing