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

NCT05743322 | Unknown

• 1 other identifier: 3D PRINT FOR TSP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Left Atrial Appendage Closure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Procedural complications

  Until 30 days after the procedure

Study Arms (1)

3D printing arm

EXPERIMENTAL

A bi-atrial 3D printed model will be manufactured before the procedure

Device: Left atrial appendage closure

Interventions

Left atrial appendage closure DEVICE

Left atrial appendage will be occluded using commercially available device

3D printing arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Brno University Hospital: collaborator
• General Teaching Hospital, Prague: collaborator

Study Sites (1)

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Pavel Osmancik

  Cardiac center University Hospital Kralovske Vinohrady

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Hozman

CONTACT

+420728135358; hozmanm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of the dept. of cardiac arrhythmias, Charles University and University Hospital Kralovske Vinohrady

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 24, 2023
• Study Start: January 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: December 31, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After 6 months after the publication, on request
• Access Criteria: On request

Locations

CZ (1)