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NCT03330210: LAA-PrintRegis

Left Atrial Appendage Occlusion Guided by 3D Printing

Completed Last updated 10 March 2020
What this trial tests

trial testing 3D printing in Atrial Fibrillation in 400 participants. Completed in 1 December 2019.

Timeline
1 December 2017
Primary endpoint
1 December 2019
1 December 2019

Quick facts

Lead sponsorUniversity Hospital, Montpellier
StatusCompleted
Study typeOBSERVATIONAL
Enrollment400
Start date1 December 2017
Primary completion1 December 2019
Estimated completion1 December 2019
Sites1 location across France

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other trials of 3D printing

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other University Hospital, Montpellier trials

Trials by the same sponsor.

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Data sources for this page

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.

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