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Enrolling by invitation Observational

Demographic and Interpopulation Variations in Evaluation and Results of TAVI

NCT07258706 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-01
Last updated
2025-12-02

Condition(s) studied

Aortic StenosisTAVI(Transcatheter Aortic Valve Implantation)Computed TomographyInflammatory Response During Cardiac SurgeryInflammation

Investigational drug(s) / intervention(s)

laboratory biomarker analysisComputed tomography of aortic root and aorta

laboratory biomarker analysis: Results of common laboratory tests obtained during routine care in the pre-procedural period (simple blood morphology, creatinine, GFR, NTproBNP). Inflammatory indices - NLR, MLR, PLR

Computed tomography of aortic root and aorta: Results of CT analysis performed as a routine diagnostic examination in the pre-procedural period will be recorded.

Study summary

The aim of the project is to evaluate demographic, clinical, and laboratory variations in patients with aortic stenosis treated with TAVI in different countries. Moreover, the study will evaluate interpopulation differences in aortic root anatomy based on computed tomography analysis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Severe aortic stenosis qualified for TAVI Exclusion Criteria: * Active infection (chronic inflammatory disease or neoplasm is not an exclusion criterion, however, will be considered in the laboratory analysis)

Primary outcome measure(s)

  • Aortic annulus diameter — Baseline
    Aortic annulus diameter in milimeters based on CT image
  • Aortic annulus area — Baseline
    Aortic annulus area in squared milimeters based on CT image
  • Aortic annulus perimeter — Baseline
    Aortic annulus perimeter in milimeters based on CT image
  • Ilio-femoral artery diameter — Baseline
    Ilio-femoral artery diameter in milimeter based on CT image
  • Neutrophils measured using whole blood count — Baseline
    This measurement is used to compute ratio of cell types using whole blood count
  • Monocytes measured in whole blood count — Baseline
    Number of monocytes identified in blood sample using automatic whole blood count. It is used to compute cell type ratio.
  • Lymphocytes measured using whole blood count — Baseline
    This measurement is used to compute ratio of cell types using whole blood count

Trial sites (5)

FacilityCityRegionStatus
San Bortolo's Hospital, Division of Cardiac Surgery and Division of Cardiology, Vicenza, Italy Vicenza Italy
Poznan University of Medical Sciences Poznan Poland
Institute for Cardiovascular Diseases of Vojvodina, Serbia University of Novi Sad Novi Sad Serbia
King Chulalongkorn Memorial Hospital, Bangkok, Thailand Bangkok Thailand
Ankara Bilkent City Hospital, Ankara, Türkiye Ankara Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07258706 on ClinicalTrials.gov ↗ ← All trials in Italy