The Usefulness of Biatrial 3D Printing to Plan Transseptal Puncture for the Left Atrial Appendage Closure
NCT ID: NCT05743322
Last Updated: 2023-02-24
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
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-01-01
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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3D printing arm
A bi-atrial 3D printed model will be manufactured before the procedure
Left atrial appendage closure
Left atrial appendage will be occluded using commercially available device
Interventions
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Left atrial appendage closure
Left atrial appendage will be occluded using commercially available device
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* non-willingness to participate
* left atrial appendage thrombus
18 Years
ALL
No
Sponsors
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Brno University Hospital
OTHER
General Teaching Hospital, Prague
OTHER
Charles University, Czech Republic
OTHER
Responsible Party
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Pavel Osmancik
head of the dept. of cardiac arrhythmias, Charles University and University Hospital Kralovske Vinohrady
Principal Investigators
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Pavel Osmancik
Role: PRINCIPAL_INVESTIGATOR
Cardiac center University Hospital Kralovske Vinohrady
Locations
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Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3D PRINT FOR TSP
Identifier Type: -
Identifier Source: org_study_id
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