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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Inflammation

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings