Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743322
Status:
RECRUITING
Last Update Posted:
2023-02-24
First Post:
2023-02-01
Brief Title:
The Usefulness of Biatrial 3D Printing to Plan Transseptal Puncture for the Left Atrial Appendage Closure
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
The Usefulness of Pre-procedural 3D Print of Both Atria to Plan Transseptal Puncture for the Left Atrial
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None