Atrial FibrillationNCT05743322
The Usefulness of Biatrial 3D Printing to Plan Transseptal Puncture for the Left Atrial Appendage Closure
A study testing Left atrial appendage closure in people with Atrial Fibrillation and Left Atrial Appendage Closure, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The aim of the study is to assess the usefulness of pre-procedural 3D printing of both atria to plan optimum site for transseptal puncture for the left atrial appendage closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Closure
- What is being tested?
- Left atrial appendage closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- atrial fibrillation (paroxysmal or non-paroxysmal)
- CHA2DS2VASc more or equal 2 (Congestive heart failure, Hypertension, Age > 75 years, Diabetes, Stroke, Vascular disease, Age > 65 years, female sex)
- Contraindications for long-term anticoagulation
Who cannot join
- allergy to contrast dye
- non-willingness to participate
- left atrial appendage thrombus
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, 10034
Pavel Osmancik, MD, PhD, 00420 ext. 721544447, pavel.osmancik@volny.cz
About this study
Official title: The Usefulness of Pre-procedural 3D Print of Both Atria to Plan Transseptal Puncture for the Left Atrial
The aim of the study is to assess the usefulness of pre-procedural 3D printing of both atria to plan optimum site for transseptal puncture for the left atrial appendage closure.
Read the detailed description
All patients referred for the left atrial appendage closure will be enrolled. Before the procedure, cardiac CT (computed tomography) will be done. Using cardiac CT, segmentation procedure will be performed. The segmented 3D biatrial reconstruction will be exported in the stereolithography (STL) format and then printed out.
Before every procedure as a part of pre-procedural planning, TSP puncture will be simulated in vitro using the three-dimensional printing (3DP) models and a 12 Fr delivery sheath. Six holes (TSP locations) through the intraatrial septum will be performed from the right side of the septum by a cordless drill. The puncture sites will be localised as follows: three in the cranial part of the fossa ovalis (FO) (anteriorly just behind the aortic root, in the middle and posteriorly) and three in the caudal portion of the FO in the identical way. The delivery sheath will be inserted through each preformed hole and its distal tip was positioned in the LAA (10 - 20 mm deep). The relationship of the sheath and the proximal LAA segment will be evaluated in two orthogonal views. Two criteria had to be met in both views to classify the puncture site as optimal: (1) a central sheath position and (2) a coaxial sheath position (the angle with the LAA ostium axis not exceeding 30°).
All procedures will be done by experienced operators according to the actual guidelines. Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) will be used. Before the procedure, each operator received a recommendation regarding the optimal puncture sites. In ICE guided cases, based on the LA anatomical structures visible in the projection plane during TSP, the puncture site was classified as posterior (left-sided pulmonary veins visible), middle (coumadin ridge visible), or anterior (LAA and mitral annulus visible). In TEE guided procedures mainly mid-oesophageal aortic valve short axis view (∼ 25-45°) and mid-oesophageal bicaval view (∼ 90-110°) will be used. Depending on in which third of the interatrial septum the puncture was performed, it will be classified as anterior, middle, or posterior (aortic valve short axis view). The bicaval projection showed the cranio-caudal localization.
The 3DP models were not used for device sizing, it was done based on the CT data and intra-procedural angiography according to the performing physicians' preferences.
The procedural difficulty will be assessed by the operator (focused on the alignment of the delivery assembly with the LAA axis). Furthermore, the number of recaptures of devices will be analyzed, as well as the number of unsuccessful procedures and procedural complications. Additional golas of the project are: to analyse the distribution of optimal puncture sites and to correlate CT 2D measurements with those findings.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure
- Being tested
- Left atrial appendage closure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial appendage closureDevice
Left atrial appendage will be occluded using commercially available device
| Study group | Role | What they receive |
|---|---|---|
| 3D printing arm | Experimental | A bi-atrial 3D printed model will be manufactured before the procedure Receives: Device: Left atrial appendage closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure satisfaction, scale 1-3 (1- optimum, 2-possible to implant, 3-impossible to implant)
The satisfaction with the transseptal puncture for the purpose of the procedure, assessed by the operator
Measured: It will be assessed immediately after the procedure, i.e. on the day of the procedure
Angle between the delivery sheath and the LAA axis
the axis between the delivery sheath with the axis of the left atrial appendage will be analysed in two orthogonal projections
Measured: It will be assessed immediately after the procedure, i.e. on the day of the procedure
Number of recaptures of the device
Number of recaptures of the device
Measured: It will be assessed immediately after the procedure, i.e. on the day of the procedure
Secondary outcomes (1)
Procedural complications
Tamponade, device embolization, stroke
Measured: Until 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Jan 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, General Teaching Hospital, Prague
- Responsible party
- Principal investigator, Pavel Osmancik, Charles University, Czech Republic
- Investigators
- Pavel Osmancik, Principal investigator, Cardiac center University Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743322
- Sponsor's protocol ID
- 3D PRINT FOR TSP
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared and available after the publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Pre-procedural 3D Print of Both Atria to Plan Transseptal Puncture for the Left Atrial
- ClinicalTrials.gov ID
- NCT05743322
- Acronym / sponsor ID
- 3D PRINT FOR TSP
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Brno University Hospital, General Teaching Hospital, Prague
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Feb 2023 (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.
The aim of the study is to assess the usefulness of pre-procedural 3D printing of both atria to plan optimum site for transseptal puncture for the left atrial appendage closure.
Detailed description
All patients referred for the left atrial appendage closure will be enrolled. Before the procedure, cardiac CT (computed tomography) will be done. Using cardiac CT, segmentation procedure will be performed. The segmented 3D biatrial reconstruction will be exported in the stereolithography (STL) format and then printed out.
Before every procedure as a part of pre-procedural planning, TSP puncture will be simulated in vitro using the three-dimensional printing (3DP) models and a 12 Fr delivery sheath. Six holes (TSP locations) through the intraatrial septum will be performed from the right side of the septum by a cordless drill. The puncture sites will be localised as follows: three in the cranial part of the fossa ovalis (FO) (anteriorly just behind the aortic root, in the middle and posteriorly) and three in the caudal portion of the FO in the identical way. The delivery sheath will be inserted through each preformed hole and its distal tip was positioned in the LAA (10 - 20 mm deep). The relationship of the sheath and the proximal LAA segment will be evaluated in two orthogonal views. Two criteria had to be met in both views to classify the puncture site as optimal: (1) a central sheath position and (2) a coaxial sheath position (the angle with the LAA ostium axis not exceeding 30°).
All procedures will be done by experienced operators according to the actual guidelines. Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) will be used. Before the procedure, each operator received a recommendation regarding the optimal puncture sites. In ICE guided cases, based on the LA anatomical structures visible in the projection plane during TSP, the puncture site was classified as posterior (left-sided pulmonary veins visible), middle (coumadin ridge visible), or anterior (LAA and mitral annulus visible). In TEE guided procedures mainly mid-oesophageal aortic valve short axis view (∼ 25-45°) and mid-oesophageal bicaval view (∼ 90-110°) will be used. Depending on in which third of the interatrial septum the puncture was performed, it will be classified as anterior, middle, or posterior (aortic valve short axis view). The bicaval projection showed the cranio-caudal localization.
The 3DP models were not used for device sizing, it was done based on the CT data and intra-procedural angiography according to the performing physicians' preferences.
The procedural difficulty will be assessed by the operator (focused on the alignment of the delivery assembly with the LAA axis). Furthermore, the number of recaptures of devices will be analyzed, as well as the number of unsuccessful procedures and procedural complications. Additional golas of the project are: to analyse the distribution of optimal puncture sites and to correlate CT 2D measurements with those findings.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D printing arm | Experimental | Device: Left atrial appendage closureA bi-atrial 3D printed model will be manufactured before the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- atrial fibrillation (paroxysmal or non-paroxysmal)
- CHA2DS2VASc more or equal 2 (Congestive heart failure, Hypertension, Age > 75 years, Diabetes, Stroke, Vascular disease, Age > 65 years, female sex)
- Contraindications for long-term anticoagulation
Key exclusion criteria (3 listed)
- allergy to contrast dye
- non-willingness to participate
- left atrial appendage thrombus
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 |
|---|---|---|
| Left atrial appendage closureLeft atrial appendage will be occluded using commercially available device | Device | 3D printing arm |
Primary outcome
Procedure satisfaction, scale 1-3 (1- optimum, 2-possible to implant, 3-impossible to implant)
Time frame: It will be assessed immediately after the procedure, i.e. on the day of the procedure
The satisfaction with the transseptal puncture for the purpose of the procedure, assessed by the operator
Angle between the delivery sheath and the LAA axis
Time frame: It will be assessed immediately after the procedure, i.e. on the day of the procedure
the axis between the delivery sheath with the axis of the left atrial appendage will be analysed in two orthogonal projections
Number of recaptures of the device
Time frame: It will be assessed immediately after the procedure, i.e. on the day of the procedure
Number of recaptures of the device
1 secondary outcome
Procedural complications
Time frame: Until 30 days after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: Yes. Data will be shared and available after the publication
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Pavel Osmancik principal investigator
Cardiac center University Hospital Kralovske Vinohrady
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left atrial appendage closure in people with Atrial Fibrillation and Left Atrial Appendage Closure, run by Charles University, Czech Republic at 1 site in Czechia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Hozman (+420728135358, hozmanm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure satisfaction, scale 1-3 (1- optimum, 2-possible to implant, 3-impossible to implant) (time frame: It will be assessed immediately after the procedure, i.e. on the day of the procedure). 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 24 Feb 2023.