The Usefulness of Biatrial 3D Printing to Plan Transseptal Puncture for the Left Atrial Appendage Closure

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Left Atrial Appendage Closure
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marek Hozman; Phone Number: +420728135358; Email: hozmanm@gmail.com

Study Locations

• Czechia
  • Prague, Czechia, 10034
    • Recruiting
    • Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• allergy to contrast dye
• non-willingness to participate
• left atrial appendage thrombus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D printing arm; A bi-atrial 3D printed model will be manufactured before the procedure	Device: Left atrial appendage closure; Left atrial appendage will be occluded using commercially available device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	It will be assessed immediately after the procedure, i.e. on the day of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural complications	Tamponade, device embolization, stroke	Until 30 days after the procedure

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Brno University Hospital; General Teaching Hospital, Prague
• Investigators: Principal Investigator: Pavel Osmančík, Cardiac center University Hospital Kralovske Vinohrady

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 3D PRINT FOR TSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared and available after the publication
• IPD Sharing Time Frame: After 6 months after the publication, on request
• IPD Sharing Access Criteria: On request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No