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Left Atrial Appendage Occlusion Guided by 3D Printing

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03330210
Acronym
LAA-PrintRegis
Enrollment
400
Registered
2017-11-06
Start date
2017-12-01
Completion date
2019-12-01
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

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

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.

Interventions

PROCEDURE3D printing

Manufacturing and use of a model printed in 3D

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* non valvular AF * adressed for LAAC procedure

Exclusion criteria

* opposition from patients

Design outcomes

Primary

MeasureTime frameDescription
operating timeDuring 1 daymesure of operating time to Day 0 (J0)
number of prothesesDuring 1 daydecrease number of prothèses to Day 0 (J0)
Implantation success rateDuring 1 dayincrease implantation success rate at Day 0 (J0)

Secondary

MeasureTime frameDescription
irradiation dose1 daydecrease of irradiation dose (mGy.cm2) at Day 0 (J0)
Days of HospitalisationDuring 1 daydischarge and decrease of hospitalisation days
number of recaptureDuring 1 daydecrease number of recapture at Day 0 (J0)
number of off-axis prosthesesDuring 1 daydecrease number of off-axis prosthèses at Day 0 (J0)
number of periprosthetic leakDuring 1 daydecrease number of periprosthetic leak at Day 0 (J0)
Effective complete occlusion of the auricle3 monthsincrease rate of Effective complete occlusion of the auricle
prosthesis trombosis12 monthsrate of prosthesis trombosis
procedural complicationsduring procedure and within 30 daysanalysis 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)
complication6 and 12 monthsanalysis 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
number of embolized prosthesesDuring 1 daydecrease number of embolized prosthèses at Day 0 (J0)
anasthesia timeDuring 1 daydecrease of anasthesia time at Day 0 (J0)
time of scopyDuring 1 daydecrease time of scopy at Day 0 (J0)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026