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

NCT05484713 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-05-16

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Cardiac imaging

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

DEVICE

3D printing of the aortic valve

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

Sponsors & Collaborators

  • George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

    collaborator OTHER

  • University Hospital of Targu Mures, Romania

    collaborator OTHER

  • Cardio Med Medical Center

    lead INDUSTRY

Principal Investigators

  • Daniel Cernica, MD · CardioMed Medical Center

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484713 on ClinicalTrials.gov