Left Atrial Appendage Occlusion Guided by 3D Printing

NCT03330210 | Completed

• 1 other identifier: RECHMPL17_0230
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

LAAC; 3D printing; Procedure success; Procedure-related complications

Outcome Measures

Primary Outcomes (3)

• operating time

  mesure of operating time to Day 0 (J0)

  During 1 day

• number of protheses

  decrease number of prothèses to Day 0 (J0)

  During 1 day

• Implantation success rate

  increase implantation success rate at Day 0 (J0)

  During 1 day

Secondary Outcomes (13)

• number of periprosthetic leak

  During 1 day

• anasthesia time

  During 1 day

• time of scopy

  During 1 day

• irradiation dose

  1 day

• Days of Hospitalisation

  During 1 day

Interventions

3D printing PROCEDURE

Manufacturing and use of a model printed in 3D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in atrial fibrillation addressed for percutaneous left atrial appendage closure intervention

You may qualify if:

• non valvular AF
• adressed for LAAC procedure

You may not qualify if:

• opposition from patients

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Hôpital Privé Les Franciscaines: collaborator
• Henri Mondor University Hospital: collaborator
• Rangueil Hospital: collaborator
• Clinique Pasteur Toulouse: collaborator
• University Hospital, Bordeaux: collaborator
• Clinique du Millenaire: collaborator
• Clinique Saint Pierre - Perpignan: collaborator
• Hôpital Dupuytren: collaborator
• Hospital St. Joseph, Marseille, France: collaborator
• European Georges Pompidou Hospital: collaborator
• University Hospital, Grenoble: collaborator
• University Hospital, Lille: collaborator

Study Sites (1)

Hôpital Privé les Franciscaines

Nîmes, 30032, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Printing, Three-Dimensional

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Technology; Technology, Industry, and Agriculture

Study Officials

• Vlad CIOBOTARU

  Hôpital Privé Les Franciscaines

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: November 6, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

FR (1)