Left Atrial Appendage Occlusion Guided by 3D Printing

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03330210
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

The 3D printing has modified the LAAC practices with a preoperative time allowing an optimal preparation of the prosthesis. This technique is now used in several surgical centers and prospective evaluation of the practice is necessary.

The objective of our research is to demonstrate the reduction of the operating time and number of prosthesis used per procedure when prior LAAC simulation testing and sizing is made on a 3D printed model.

It is therefore a longitudinal research to monitor professional practices for the evaluation of a new preoperative approach.

Procedures guided by 3Dprinted models will be compared (intention to treat population) in term of procedural parameters (procedure time, success rate, number of prosthesis per procedure) and procedural complication with prior Watchman study: post-FDA Approval US experience and national registries data. A second analysis (per protocol population) will be performed to compare patients with an informative utilization guided by 3D printed to those of the post-FDA Approval US experience and national registries.

Study Timeline

• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-06
• Study Start: 2017-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• non valvular AF
• adressed for LAAC procedure

Exclusion Criteria

• opposition from patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
operating time	During 1 day	mesure of operating time to Day 0 (J0)
number of protheses	During 1 day	decrease number of prothèses to Day 0 (J0)
Implantation success rate	During 1 day	increase implantation success rate at Day 0 (J0)

Secondary Outcome Measures

Name	Time	Method
Effective complete occlusion of the auricle	6 months	increase rate of Effective complete occlusion of the auricle
anasthesia time	During 1 day	decrease of anasthesia time at Day 0 (J0)
time of scopy	During 1 day	decrease time of scopy at Day 0 (J0)
irradiation dose	1 day	decrease of irradiation dose (mGy.cm2) at Day 0 (J0)
number of recapture	During 1 day	decrease number of recapture at Day 0 (J0)
prosthesis trombosis	12 months	rate of prosthesis trombosis
number of periprosthetic leak	During 1 day	decrease number of periprosthetic leak at Day 0 (J0)
Days of Hospitalisation	During 1 day	discharge and decrease of hospitalisation days
number of off-axis prostheses	During 1 day	decrease number of off-axis prosthèses at Day 0 (J0)
number of embolized prostheses	During 1 day	decrease number of embolized prosthèses at Day 0 (J0)
procedural complications	during procedure and within 30 days	analysis of complications (Stroke, transient ischaemic attack, peripheral embolism, Pericardial effusion and tamponade Bleeding, Life threatening, major and minor, Acces related complications, Renal or hepatic acute failure)
complication	6 and 12 months	analysis of complications (Stroke, transient ischaemic attack, peripheral embolism, Pericardial effusion and tamponade Bleeding, Life threatening, major and minor, Acces related complications, Renal or hepatic acute failure) at 6 and 12 months

Trial Locations

Locations (1)

Hôpital Privé les Franciscaines; 🇫🇷 Nîmes, France