Left Atrial Appendage Occlusion Guided by 3D Printing

Summary

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.

Conditions

• Atrial Fibrillation

Interventions

PROCEDURE

3D printing

Manufacturing and use of a model printed in 3D

Sponsors & Collaborators

• Hôpital Privé Les Franciscaines

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Rangueil Hospital

  collaborator OTHER

• Clinique Pasteur Toulouse

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Clinique du Millenaire

  collaborator OTHER

• Clinique Saint Pierre - Perpignan

  collaborator UNKNOWN

• Hôpital Dupuytren

  collaborator OTHER

• Hospital St. Joseph, Marseille, France

  collaborator OTHER

• European Georges Pompidou Hospital

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Vlad CIOBOTARU · Hôpital Privé Les Franciscaines

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2019-12-01

Completion

2019-12-01

Countries

• France

Study Locations