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NCT Number: NCT07258706

Demographic and Interpopulation Variations in Evaluation and Results of TAVI

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Computed Tomography Heart Diseases Heart Valve Diseases Inflammation Inflammatory Response During Cardiac Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms TAVI(Transcatheter Aortic Valve Implantation) Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Bortolo's Hospital, Division of Cardiac Surgery and Division of Cardiology, Vicenza, Italy, Vicenza, Italy

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About this study

Aortic stenosis represents the most common valvular heart disease in developed countries, with a significant epidemiologic increase related to the aging population. Currently, surgical and transcatheter interventions are the only therapeutic options, as pharmacotherapy is still insufficient in the disease management. Transcatheter aortic valve implantation is recommended in selected groups of patients and provides optimal short and long-term outcomes.

Racial and ethnic disparities in aortic stenosis prevalence, management, and outcomes of treatment have been postulated. Data on discrepancies in aortic stenosis characteristics in patients qualified for transcatheter aortic valve implantation across populations are lacking.

The current project will conduct the analysis in populations of patients with aortic stenosis qualified for transcatheter aortic valve implantation from different countries to reveal potential disparities in clinical characteristics and in requirements for variations in prostheses sizes.

This is a retrospective, multicentre, observational registry of patients with severe aortic stenosis qualified for transcatheter aortic valve implantation.

Inclusion criteria

- each site will include consecutive 100 patients who underwent transcatheter aortic valve implantation between January and June 2025.

Exclusion criteria

- active infection (chronic inflammatory disease or neoplasm is not an exclusion criterion, however, will be considered in the laboratory analysis)

Data concerning

  • patients' demographics,
  • clinical characteristics
  • results of aortic root and aorta analyses by computed tomography
  • echocardiography results
  • results of common laboratory tests (blood morphology, inflammatory ratios of neutrophils, monocytes and platelets to lymphocytes, glomerular filtration rate, N-terminal prohormone of brain natriuretic peptide) obtained during the routine care in the pre-procedural period will be collected at each site.

Simple procedural results (inc. prosthesis type and size) and outcomes (survival, bleeding, vascular complications, and acute kidney injury) will be recorded.

Collected data will be compared between study populations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

laboratory biomarker analysis

Diagnostic Test

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

Diagnostic Test

Results of CT analysis performed as a routine diagnostic examination in the pre-procedural period will be recorded.

Primary outcomes

  1. Aortic annulus diameter

    Time frame: Baseline

    Aortic annulus diameter in milimeters based on CT image

  2. Aortic annulus area

    Time frame: Baseline

    Aortic annulus area in squared milimeters based on CT image

  3. Aortic annulus perimeter

    Time frame: Baseline

    Aortic annulus perimeter in milimeters based on CT image

  4. Ilio-femoral artery diameter

    Time frame: Baseline

    Ilio-femoral artery diameter in milimeter based on CT image

  5. Neutrophils measured using whole blood count

    Time frame: Baseline

    This measurement is used to compute ratio of cell types using whole blood count

  6. Monocytes measured in whole blood count

    Time frame: Baseline

    Number of monocytes identified in blood sample using automatic whole blood count. It is used to compute cell type ratio.

  7. Lymphocytes measured using whole blood count

    Time frame: Baseline

    This measurement is used to compute ratio of cell types using whole blood count

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

DIVER-TAVI Registry - Demographic and Interpopulation Variations in Evaluation and Results of TAVI

Acronym: DIVER-TAVI

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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