Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure

NCT05484713 | Unknown

• 1 other identifier: CM-G510-3DP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Aortic Stenosis; Valvular Cardiomyopathy; Aortic Valve Disease

Keywords

aortic stenosis; 3D printing; interventional planning; cardiovascular models; TAVI; Accuracy

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Cardiac imaging DIAGNOSTIC_TEST

Baseline - 2D transthoracic echocardiography, 128-multislice CT coronary angiography, CCTA of peripheral lower limbs vessels 12-months follow-up - 128-multislice CT coronary angiography with transthoracic echocardiography

3D printing of the aortic valve DEVICE

3D printing of the aortic valve based on CCTA image acquisition

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardio Med Medical Center: lead
• George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures: collaborator
• University Hospital of Targu Mures, Romania: collaborator

Study Sites (1)

Cardio Med Medical Center

Târgu Mureş, 540124, Romania

RECRUITING

Related Publications (4)

• 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.

  PMID: 34575059 BACKGROUND

• 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.

  PMID: 31130624 BACKGROUND

• 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.

  PMID: 32861647 BACKGROUND

• 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.

  PMID: 28183437 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Daniel Cernica, MD

  CardioMed Medical Center

  STUDY DIRECTOR

Central Study Contacts

Daniel Cernica, MD

CONTACT

+40 265 217 333; daniel.cernica@gmail.com

Theodora Benedek, Professor

CONTACT

+40 265 217 333; theodora.benedek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 2, 2022
• Study Start: July 8, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The IPD sharing frame is starting 6 months after publication.

Locations

RO (1)