Clinical trial NCT03330210: Left Atrial Appendage Occlusion Guided by 3D Printing
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: LAAC
3D printing
Procedure success
Procedure-related complications
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Hôpital Privé Les Franciscaines
name: Henri Mondor University Hospital
name: Rangueil Hospital
name: Clinique Pasteur Toulouse
name: University Hospital, Bordeaux
name: Clinique du Millenaire
name: Clinique Saint Pierre - Perpignan
name: Hôpital Dupuytren
name: Hospital St. Joseph, Marseille, France
name: European Georges Pompidou Hospital
name: University Hospital, Grenoble
name: University Hospital, Lille
First posted: 2017-11-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in atrial fibrillation addressed for percutaneous left atrial appendage closure intervention

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.

Eligibility criteria: Inclusion Criteria:

* non valvular AF
* adressed for LAAC procedure

Exclusion Criteria:

* opposition from patients

Primary outcomes:
measure: operating time
timeFrame: During 1 day
measure: number of protheses
timeFrame: During 1 day
measure: Implantation success rate
timeFrame: During 1 day
Secondary outcomes:
measure: number of periprosthetic leak
timeFrame: During 1 day
measure: anasthesia time
timeFrame: During 1 day
measure: time of scopy
timeFrame: During 1 day
measure: irradiation dose
timeFrame: 1 day
measure: Days of Hospitalisation
timeFrame: During 1 day
measure: number of recapture
timeFrame: During 1 day
measure: number of off-axis prostheses
timeFrame: During 1 day
measure: number of embolized prostheses
timeFrame: During 1 day
measure: Effective complete occlusion of the auricle
timeFrame: 3 months
measure: Effective complete occlusion of the auricle
timeFrame: 6 months
measure: prosthesis trombosis
timeFrame: 12 months
measure: procedural complications
timeFrame: during procedure and within 30 days
measure: complication
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Hôpital Privé les Franciscaines
Study officials:
affiliation: Hôpital Privé Les Franciscaines
name: Vlad CIOBOTARU
role: STUDY_CHAIR
References: