Left Atrial Appendage Occlusion Guided by 3D Printing (LAA-PrintRegis)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: 3D printing

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30032
    • Hôpital Privé Les Franciscaines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• non valvular AF
• adressed for LAAC procedure

Exclusion Criteria:

• opposition from patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of periprosthetic leak	decrease number of periprosthetic leak at Day 0 (J0)	During 1 day
anasthesia time	decrease of anasthesia time at Day 0 (J0)	During 1 day
time of scopy	decrease time of scopy at Day 0 (J0)	During 1 day
irradiation dose	decrease of irradiation dose (mGy.cm2) at Day 0 (J0)	1 day
Days of Hospitalisation	discharge and decrease of hospitalisation days	During 1 day
number of recapture	decrease number of recapture at Day 0 (J0)	During 1 day
number of off-axis prostheses	decrease number of off-axis prosthèses at Day 0 (J0)	During 1 day
number of embolized prostheses	decrease number of embolized prosthèses at Day 0 (J0)	During 1 day
Effective complete occlusion of the auricle	increase rate of Effective complete occlusion of the auricle	3 months
Effective complete occlusion of the auricle	increase rate of Effective complete occlusion of the auricle	6 months
prosthesis trombosis	rate of prosthesis trombosis	12 months
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Bordeaux; University Hospital, Grenoble; University Hospital, Lille; Hospital St. Joseph, Marseille, France; Henri Mondor University Hospital; European Georges Pompidou Hospital; Clinique Pasteur Toulouse; Rangueil Hospital; Clinique du Millenaire; Clinique Saint Pierre - Perpignan; Hôpital Dupuytren; Hôpital Privé Les Franciscaines
• Investigators: Study Chair: Vlad CIOBOTARU, Hôpital Privé Les Franciscaines

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (ACTUAL): November 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: 3D printing; LAAC; Procedure success; Procedure-related complications
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RECHMPL17_0230

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No