Skip to main content
OpenTrials
Completed

NCT Number: NCT03330210

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé les Franciscaines

Nîmes, 30032, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • non valvular AF
  • adressed for LAAC procedure

Exclusion criteria

  • opposition from patients

Treatment and study plan

3D printing

Procedure

Manufacturing and use of a model printed in 3D

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Official study 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

Acronym: LAA-PrintRegis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.