Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure (3DP-FAST)

Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure -the 3DP-FAST Study

• The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI procedure. By conducting a comparative analysis of measurements achieved on CCTA images versus measurements obtained with a specialized projection platform by photogrammetry vs 3D printed models of various aortic valvular and perivalvular structures will be evaluated the accuracy of each step of image dataset processing. Furthermore, the study will evaluate the rate of valvular leak or peri-procedural complications such as embolic events or atrio-ventricular conduction block based on coronary computed tomography angiographic and ECG assessment at 1 year after enrollment.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Aortic Valve Disease; Valvular Cardiomyopathy
• Intervention / Treatment: Diagnostic test: Cardiac imaging; Device: 3D printing of the aortic valve

Detailed Description

The project is a prospective, cohort, mono-centric study which will be carried out in CardioMed Medical Center in collaboration with the University of Medicine, Pharmacy, Science and Technology "George Emil Palade" of Târgu Mureș.

The project will include 20 subjects who present severe aortic stenosis prior to study enrollment.

Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVI by the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed Heart Valve Team.

All patients will undergo coronary CT angiography, cardiac perfusion CT and peripheral CT angiography at the moment of enrollment in the study, for complex assessment of aortic valvular and perivalvular structures as well as for peripheral vascular approach.

The study will be conducted over a period of 1 year, in which patients will be examined at baseline, and during follow-up visit. At the one-year follow-up, the study subjects will undergo CT coronary angiography for re-evaluation of the aortic valve, in the prospects of analyzing the rate of valvular leak or peri-procedural complications such as embolic events or atrio-ventricular conduction block. In case of non-presentation for the follow-up visit, patients will be contacted via telephone by one of the investigators, and questioned about the general health status, occurrence of cardiovascular or cerebrovascular symptoms and interventions, for possible non-cardiovascular related hospitalizations, as well as regarding the presence of aortic valvular disease rates/repeated interventions.

All patients will sign an informed written consent prior to being enrolled in the study. After the screening process, patients that do not present exclusion criteria will be enrolled in the study.

Study objectives:

Primary: to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI procedure

Secondary: re-evaluation of the aortic valve, in the prospects of analyzing the rate of valvular leak or peri-procedural complications such as embolic events or atrio-ventricular conduction block.

Study Timeline:

Baseline (day 0)

• Obtain and document consent from participant on study consent form.
• Verify inclusion/exclusion criteria.
• Obtain demographic information, medical history, medication history, alcohol and tobacco use history.
• Record results of physical examinations and 12-lead ECG.
• Imaging procedures: transthoracic 2-D echocardiography, 128-multislice CT angiography (CCTA)
• 3d printed model by FDM technique based on CCTA
• Evaluation of 3D printing workflow accuracy Visit 2 (month 6)
• Follow-up after TAVI procedure
• Record results of physical examinations, 12-lead ECG and medical history.
• Imaging procedures: transthoracic 2-D echocardiography Final study visit (month 12)
• Record results of physical examinations, 12-lead ECG and medical history.
• Imaging procedures: transthoracic 2-D echocardiography, 128-multisclice CCTA
• End-point evaluation.

Study procedures:

• Clinical examination, medical history
• 12-lead ECG
• 2D transthoracic echocardiography with measurement of: cardiac diameters, volumes, valvular function and regurgitation, pressure gradients, pericardial fat thickness, pericardial effusion, left ventricular global and regional function and ejection fraction.
• 128-multislice CT coronary angiography with the evaluation of: epicardial fat volume, coronary plaque burden, total and local calcium score, aortic valve, perivalvular aortic structures, peripheral iliac vessels, ascending and descending segments of aorta.
• Processing of DICOM image dataset by performing segmentation and STL adjustments
• Processing STL image dataset by performing CAD analysis and adjustments
• Processing G-code image dataset and sending to 3d printing station
• 3D printing of aortic model including perivalvular aortic structures using fused filaments method

Data collection: In a dedicated database that includes all patient information, demographics, medical history, medication, therapeutic procedures, information derived from imaging techniques (echocardiography, CT angiography, CT imaging post-processing and shear stress evaluation).

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Daniel Cernica, MD; Phone Number: +40 265 217 333; Email: daniel.cernica@gmail.com
• Study Contact Backup: Name: Theodora Benedek, Professor; Phone Number: +40 265 217 333; Email: theodora.benedek@gmail.com

Study Locations

• Romania
  • Targu Mures, Romania, 540124
    • Recruiting
    • Cardio Med Medical Center
    • Contact: Theodora Benedek, PhD, MD; Phone Number: +40-265-217-333; Email: theodora.benedek@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with a minimum age of 60 years old, with severe degenerative aortic stenosis who present the criteria for transcatheter aortic valve intervention, who undergo coronary CCTA and CT angiography of the abdominal aorta and lower limbs, and who do not require the criteria for surgical aortic valve replacement.

Description

Inclusion Criteria:

• patients with degenerative aortic stenosis who present the criteria for transcatheter aortic valve intervention, who undergo coronary CCTA and CT angiography of the abdominal aorta and lower limbs.

Exclusion Criteria:

• contraindications for TAVI procedures
• patients that undergo surgical aortic valve replacement for aortic stenosis
• patients with contraindications for iodine contrast agent administration (acute renal failure, allergy, thyroid dysfunction).
• other conditions associated with suboptimal CCTA image acquisition which could interfere with CT image postprocessing for creation of 3D printed models.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of 3D printed models of aortic valves in guiding TAVI procedure	Analysis of the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI procedure.	at baseline
Rate of complications during 12 months follow-up of patients undergoing TAVI for aortic stenosis	Re-evaluation of the aortic valve, in the prospects of analyzing the rate of valvular leak or peri-procedural complications such as embolic events or atrio-ventricular conduction block during a 12 months follow-up after TAVI procedure.	12 months

Collaborators and Investigators

• Sponsor: Cardio Med Medical Center
• Collaborators: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures; University Hospital of Targu Mures, Romania
• Investigators: Study Director: Daniel Cernica, MD, Cardiomed Medical Center

Publications and helpful links

General Publications

• Cernica D, Benedek I, Polexa S, Tolescu C, Benedek T. 3D Printing-A Cutting Edge Technology for Treating Post-Infarction Patients. Life (Basel). 2021 Sep 1;11(9):910. doi: 10.3390/life11090910.
• Benedek A, Cernica D, Mester A, Opincariu D, Hodas R, Rodean I, Keri J, Benedek T. Modern Concepts in Regenerative Therapy for Ischemic Stroke: From Stem Cells for Promoting Angiogenesis to 3D-Bioprinted Scaffolds Customized via Carotid Shear Stress Analysis. Int J Mol Sci. 2019 May 25;20(10):2574. doi: 10.3390/ijms20102574.
• Wang DD, Qian Z, Vukicevic M, Engelhardt S, Kheradvar A, Zhang C, Little SH, Verjans J, Comaniciu D, O'Neill WW, Vannan MA. 3D Printing, Computational Modeling, and Artificial Intelligence for Structural Heart Disease. JACC Cardiovasc Imaging. 2021 Jan;14(1):41-60. doi: 10.1016/j.jcmg.2019.12.022. Epub 2020 Aug 26.
• Vukicevic M, Mosadegh B, Min JK, Little SH. Cardiac 3D Printing and its Future Directions. JACC Cardiovasc Imaging. 2017 Feb;10(2):171-184. doi: 10.1016/j.jcmg.2016.12.001.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: July 30, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Accuracy; aortic stenosis; TAVI; 3D printing; interventional planning; cardiovascular models
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic; Cardiomyopathies; Aortic Valve Disease
• Other Study ID Numbers: CM-G510-3DP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be available for interested parties.
• IPD Sharing Time Frame: The IPD sharing frame is starting 6 months after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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