Demographic and Interpopulation Variations in Evaluation and Results of TAVI (DIVER-TAVI)

November 20, 2025 updated by: Poznan University of Medical Sciences

DIVER-TAVI Registry - 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Vicenza, Italy
        • San Bortolo's Hospital, Division of Cardiac Surgery and Division of Cardiology, Vicenza, Italy
  • Poland
      • Poznan, Poland, 61-848
        • Poznan University of Medical Sciences
  • Serbia
      • Novi Sad, Serbia
        • Institute for Cardiovascular Diseases of Vojvodina, Serbia University of Novi Sad
  • Thailand
      • Bangkok, Thailand
        • King Chulalongkorn Memorial Hospital, Bangkok, Thailand
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Ankara Bilkent City Hospital, Ankara, Türkiye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients qualified for TAVI will be included in the analysis and compared in subpopulations.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with aortic stenosis qualified for TAVI
All consecutive patients with severe aortic stenosis qualified for TAVI according to current guidelines
Diagnostic test: 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
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortic annulus diameter
Time Frame: Baseline
Aortic annulus diameter in milimeters based on CT image
Baseline
Aortic annulus area
Time Frame: Baseline
Aortic annulus area in squared milimeters based on CT image
Baseline
Aortic annulus perimeter
Time Frame: Baseline
Aortic annulus perimeter in milimeters based on CT image
Baseline
Ilio-femoral artery diameter
Time Frame: Baseline
Ilio-femoral artery diameter in milimeter based on CT image
Baseline
Neutrophils measured using whole blood count
Time Frame: Baseline
This measurement is used to compute ratio of cell types using whole blood count
Baseline
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.
Baseline
Lymphocytes measured using whole blood count
Time Frame: Baseline
This measurement is used to compute ratio of cell types using whole blood count
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Principal Investigator: Anna Olasinska-Wisniewska, Poznan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 12, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025_538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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