Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
400 participants
OBSERVATIONAL
2017-12-01
2019-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis
NCT01398033
STREAMER : STent Restenosis And MEdicaments Release
NCT02835586
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
NCT02942966
Paclitaxel Eluting Stent in Long SFA Obstruction: A Prospective, Randomized Comparison With Bypass Surgery
NCT01450722
Local Paclitaxel or Balloon Angioplasty Below the Knee
NCT03149913
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3D printing
Manufacturing and use of a model printed in 3D
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* adressed for LAAC procedure
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hôpital Privé Les Franciscaines
OTHER
Henri Mondor University Hospital
OTHER
Rangueil Hospital
OTHER
Clinique Pasteur Toulouse
OTHER
University Hospital, Bordeaux
OTHER
Clinique du Millenaire
OTHER
Clinique Saint Pierre - Perpignan
UNKNOWN
Hôpital Dupuytren
OTHER
Hospital St. Joseph, Marseille, France
OTHER
European Georges Pompidou Hospital
OTHER
University Hospital, Grenoble
OTHER
University Hospital, Lille
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vlad CIOBOTARU
Role: STUDY_CHAIR
Hôpital Privé Les Franciscaines
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Privé les Franciscaines
Nîmes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RECHMPL17_0230
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.