Left Atrial Appendage Occlusion Guided by 3D Printing

Atrial Fibrillation Clinical Trial

— LAA-PrintRegis  

Official title:

National Longitudinal Registry for Mid-Term Clinical Outcome And Procedure Efficacy Evaluation In Using A Novel Preprocedural Planning Method For Left Atrial Appendage Occlusion Guided By 3D Printing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330210
• Other study ID #: RECHMPL17_0230
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• non valvular AF

• adressed for LAAC procedure

Exclusion Criteria:

• opposition from patients

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• 3D printing
Manufacturing and use of a model printed in 3D

Locations

Country	Name	City	State
France	Hôpital Privé les Franciscaines	Nîmes

Sponsors (13)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Clinique du Millénaire - Montpellier, Clinique Pasteur Toulouse, Clinique Saint Pierre - Perpignan, European Georges Pompidou Hospital, Henri Mondor University Hospital, Hôpital Dupuytren, Hôpital Privé Les Franciscaines, Hospital St. Joseph, Marseille, France, Rangueil Hospital, University Hospital, Bordeaux, University Hospital, Grenoble, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operating time	mesure of operating time to Day 0 (J0)	During 1 day
Primary	number of protheses	decrease number of prothèses to Day 0 (J0)	During 1 day
Primary	Implantation success rate	increase implantation success rate at Day 0 (J0)	During 1 day
Secondary	number of periprosthetic leak	decrease number of periprosthetic leak at Day 0 (J0)	During 1 day
Secondary	anasthesia time	decrease of anasthesia time at Day 0 (J0)	During 1 day
Secondary	time of scopy	decrease time of scopy at Day 0 (J0)	During 1 day
Secondary	irradiation dose	decrease of irradiation dose (mGy.cm2) at Day 0 (J0)	1 day
Secondary	Days of Hospitalisation	discharge and decrease of hospitalisation days	During 1 day
Secondary	number of recapture	decrease number of recapture at Day 0 (J0)	During 1 day
Secondary	number of off-axis prostheses	decrease number of off-axis prosthèses at Day 0 (J0)	During 1 day
Secondary	number of embolized prostheses	decrease number of embolized prosthèses at Day 0 (J0)	During 1 day
Secondary	Effective complete occlusion of the auricle	increase rate of Effective complete occlusion of the auricle	3 months
Secondary	Effective complete occlusion of the auricle	increase rate of Effective complete occlusion of the auricle	6 months
Secondary	prosthesis trombosis	rate of prosthesis trombosis	12 months
Secondary	procedural complications	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)	during procedure and within 30 days
Secondary	complication	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	6 and 12 months