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NCT03330210: LAA-PrintRegis
Left Atrial Appendage Occlusion Guided by 3D Printing
trial testing 3D printing in Atrial Fibrillation in 400 participants. Completed in 1 December 2019.
1 December 2019
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 1 December 2017 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- 3D printing
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
University Hospital, Montpellier
Who can join
18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Left atrial appendage closure (LAAC) was approved by the ESC guidelines as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation in patients at high risk of bleeding (IIbB). Although the overall LAAC benefice, in term of prevention of stroke or embolisme and decresing the anticoagulant-related risk of bleeding is already demonstrated, however the procedure success and safety, critically depends on understanding LAA anatomy and adequate pre-procedure planning. 3D-printed patient-specific adaptive and flexible LA models have demonstrated in a previous study an improving in LAAO device sizing, a better pre-procedural planning of the optimal trans-septal puncture site, by incorporating all anatomical variations and an improuving patient outcomes by reducing procedure time and number of prostheses employed per patient. This technique is now used in several surgical centers in France and large prospective evaluation of the practice is necessary.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
From ideas to long-term studies: 3D printing clinical trials review.
Witowski J, Sitkowski M, Zuzak T, Coles-Black J, et al · · 2018 · cited 39× · PMID 29790077 · DOI 10.1007/s11548-018-1793-8 -
Complex transcatheter left atrial appendage closure using a tailored trans-jugular approach simulated by 3D printing: a case report.
Ciobotaru V, Tadros VX, Martin CA, Hascoet S. · · 2022 · cited 5× · PMID 35965604 · DOI 10.1093/ehjcr/ytac304 -
Retro-Curve Access Sheath for Retroverted Anatomy in Left Atrial Appendage Closure: Bench Validation and Patient-Specific Simulation Study.
Ciobotaru V, Elbaz M, Iriart X, Bouisset F, et al · · 2026 · PMID 42016807 · DOI 10.1016/j.shj.2026.100820
Verify or expand the search:
- PubMed search for NCT03330210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other University Hospital, Montpellier trials
Trials by the same sponsor.
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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 NCT03330210 (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 University Hospital, Montpellier
- Last refreshed: 10 March 2020
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/NCT03330210.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing