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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330210
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Hôpital Privé Les Franciscaines
Henri Mondor University Hospital
Rangueil Hospital
Clinique Pasteur Toulouse
University Hospital, Bordeaux
Clinique du Millénaire - Montpellier
Clinique Saint Pierre - Perpignan
Hôpital Dupuytren
Hospital St. Joseph, Marseille, France
European Georges Pompidou Hospital
University Hospital, Grenoble
University Hospital, Lille
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Atrial Fibrillation 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.

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. operating time [ Time Frame: During 1 day ]
    mesure of operating time to Day 0 (J0)

  2. number of protheses [ Time Frame: During 1 day ]
    decrease number of prothèses to Day 0 (J0)

  3. Implantation success rate [ Time Frame: During 1 day ]
    increase implantation success rate at Day 0 (J0)


Secondary Outcome Measures :
  1. number of periprosthetic leak [ Time Frame: During 1 day ]
    decrease number of periprosthetic leak at Day 0 (J0)

  2. anasthesia time [ Time Frame: During 1 day ]
    decrease of anasthesia time at Day 0 (J0)

  3. time of scopy [ Time Frame: During 1 day ]
    decrease time of scopy at Day 0 (J0)

  4. irradiation dose [ Time Frame: 1 day ]
    decrease of irradiation dose (mGy.cm2) at Day 0 (J0)

  5. Days of Hospitalisation [ Time Frame: During 1 day ]
    discharge and decrease of hospitalisation days

  6. number of recapture [ Time Frame: During 1 day ]
    decrease number of recapture at Day 0 (J0)

  7. number of off-axis prostheses [ Time Frame: During 1 day ]
    decrease number of off-axis prosthèses at Day 0 (J0)

  8. number of embolized prostheses [ Time Frame: During 1 day ]
    decrease number of embolized prosthèses at Day 0 (J0)

  9. Effective complete occlusion of the auricle [ Time Frame: 3 months ]
    increase rate of Effective complete occlusion of the auricle

  10. Effective complete occlusion of the auricle [ Time Frame: 6 months ]
    increase rate of Effective complete occlusion of the auricle

  11. prosthesis trombosis [ Time Frame: 12 months ]
    rate of prosthesis trombosis

  12. procedural complications [ Time Frame: 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)

  13. complication [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in atrial fibrillation addressed for percutaneous left atrial appendage closure intervention
Criteria

Inclusion Criteria:

  • non valvular AF
  • adressed for LAAC procedure

Exclusion Criteria:

  • opposition from patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330210


Locations
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France
Hôpital Privé les Franciscaines
Nîmes, France, 30032
Sponsors and Collaborators
University Hospital, Montpellier
Hôpital Privé Les Franciscaines
Henri Mondor University Hospital
Rangueil Hospital
Clinique Pasteur Toulouse
University Hospital, Bordeaux
Clinique du Millénaire - Montpellier
Clinique Saint Pierre - Perpignan
Hôpital Dupuytren
Hospital St. Joseph, Marseille, France
European Georges Pompidou Hospital
University Hospital, Grenoble
University Hospital, Lille
Investigators
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Study Chair: Vlad CIOBOTARU Hôpital Privé Les Franciscaines
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03330210    
Other Study ID Numbers: RECHMPL17_0230
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
LAAC
3D printing
Procedure success
Procedure-related complications
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes