Atrial FibrillationLAA-PrintRegisNCT03330210
Left Atrial Appendage Occlusion Guided by 3D Printing
An observational study of Atrial Fibrillation, run by University Hospital, Montpellier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 3D printing
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in atrial fibrillation addressed for percutaneous left atrial appendage closure intervention
Who may be able to join
- non valvular AF
- adressed for LAAC procedure
Who cannot join
- opposition from patients
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- 3D printing
- Keywords
- LAAC, 3D printing, Procedure success, Procedure-related complications
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printingProcedure or surgery
Manufacturing and use of a model printed in 3D
What is being measured
The primary outcome is the main question the study is designed to answer.
operating time
mesure of operating time to Day 0 (J0)
Measured: During 1 day
number of protheses
decrease number of prothèses to Day 0 (J0)
Measured: During 1 day
Implantation success rate
increase implantation success rate at Day 0 (J0)
Measured: During 1 day
Secondary outcomes (13)
number of periprosthetic leak
decrease number of periprosthetic leak at Day 0 (J0)
Measured: During 1 day
anasthesia time
decrease of anasthesia time at Day 0 (J0)
Measured: During 1 day
time of scopy
decrease time of scopy at Day 0 (J0)
Measured: During 1 day
irradiation dose
decrease of irradiation dose (mGy.cm2) at Day 0 (J0)
Measured: 1 day
Days of Hospitalisation
discharge and decrease of hospitalisation days
Measured: During 1 day
number of recapture
decrease number of recapture at Day 0 (J0)
Measured: During 1 day
number of off-axis prostheses
decrease number of off-axis prosthèses at Day 0 (J0)
Measured: During 1 day
number of embolized prostheses
decrease number of embolized prosthèses at Day 0 (J0)
Measured: During 1 day
Effective complete occlusion of the auricle
increase rate of Effective complete occlusion of the auricle
Measured: 3 months
Effective complete occlusion of the auricle
increase rate of Effective complete occlusion of the auricle
Measured: 6 months
prosthesis trombosis
rate of prosthesis trombosis
Measured: 12 months
procedural complications
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)
Measured: during procedure and within 30 days
complication
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
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Privé Les Franciscaines, Henri Mondor University Hospital, Rangueil Hospital, Clinique Pasteur Toulouse, University Hospital, Bordeaux, Clinique du Millenaire, Clinique Saint Pierre - Perpignan, Hôpital Dupuytren, Hospital St. Joseph, Marseille, France, European Georges Pompidou Hospital, University Hospital, Grenoble, University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Vlad CIOBOTARU, Study chair, Hôpital Privé Les Franciscaines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330210
- Sponsor's protocol ID
- RECHMPL17_0230
- Acronym
- LAA-PrintRegis
- Status last verified
- Mar 2020
- First submitted
- 11 Oct 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03330210
- Acronym / sponsor ID
- LAA-PrintRegis / RECHMPL17_0230
- Conditions
- Atrial Fibrillation
- Keywords
- LAAC, 3D printing, Procedure success, Procedure-related complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hôpital Privé Les Franciscaines, Henri Mondor University Hospital, Rangueil Hospital, Clinique Pasteur Toulouse, University Hospital, Bordeaux, Clinique du Millenaire, Clinique Saint Pierre - Perpignan, Hôpital Dupuytren, Hospital St. Joseph, Marseille, France, European Georges Pompidou Hospital, University Hospital, Grenoble, University Hospital, Lille
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in atrial fibrillation addressed for percutaneous left atrial appendage closure intervention
Key inclusion criteria (2 listed)
- non valvular AF
- adressed for LAAC procedure
Key exclusion criteria (1 listed)
- opposition from patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printingManufacturing and use of a model printed in 3D | Procedure or surgery | – |
Primary outcome
operating time
Time frame: During 1 day
mesure of operating time to Day 0 (J0)
number of protheses
Time frame: During 1 day
decrease number of prothèses to Day 0 (J0)
Implantation success rate
Time frame: During 1 day
increase implantation success rate at Day 0 (J0)
13 secondary outcomes
number of periprosthetic leak
Time frame: During 1 day
anasthesia time
Time frame: During 1 day
time of scopy
Time frame: During 1 day
irradiation dose
Time frame: 1 day
Days of Hospitalisation
Time frame: During 1 day
number of recapture
Time frame: During 1 day
number of off-axis prostheses
Time frame: During 1 day
number of embolized prostheses
Time frame: During 1 day
Effective complete occlusion of the auricle
Time frame: 3 months
Effective complete occlusion of the auricle
Time frame: 6 months
prosthesis trombosis
Time frame: 12 months
procedural complications
Time frame: during procedure and within 30 days
complication
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vlad CIOBOTARU study chair
Hôpital Privé Les Franciscaines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operating time (time frame: During 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.