Aortic StenosisDIVER-TAVINCT07258706
Demographic and Interpopulation Variations in Evaluation and Results of TAVI
An observational study of Aortic Stenosis and TAVI(Transcatheter Aortic Valve Implantation), run by Poznan University of Medical Sciences at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Computed Tomography
- What is being tested?
- laboratory biomarker analysis and Computed tomography of aortic root and aorta
- How many people
- 800 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Jan 2025to Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients qualified for TAVI will be included in the analysis and compared in subpopulations.
Who may be able to join
- Severe aortic stenosis qualified for TAVI
Who cannot join
- Active infection (chronic inflammatory disease or neoplasm is not an exclusion criterion, however, will be considered in the laboratory analysis)
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Italy1 site
San Bortolo's Hospital, Division of Cardiac Surgery and Division of Cardiology, Vicenza, Italy
Vicenza
Serbia1 site
Institute for Cardiovascular Diseases of Vojvodina, Serbia University of Novi Sad
Novi Sad
Thailand1 site
King Chulalongkorn Memorial Hospital, Bangkok, Thailand
Bangkok
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital, Ankara, Türkiye
Ankara
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Computed Tomography, Inflammatory Response During Cardiac Surgery, Inflammation
- Being tested
- laboratory biomarker analysis, Computed tomography of aortic root and aorta
- Keywords
- Aortic stenosis, transcatheter aortic valve implantation, TAVI, Computed Tomography, Inflammation
- Medical subject headings
- Aortic Valve Stenosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisDiagnostic 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 aortaDiagnostic test
Results of CT analysis performed as a routine diagnostic examination in the pre-procedural period will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Patients with aortic stenosis qualified for TAVI | All consecutive patients with severe aortic stenosis qualified for TAVI according to current guidelines Receives: Diagnostic Test: laboratory biomarker analysis; Diagnostic Test: Computed tomography of aortic root and aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic annulus diameter
Aortic annulus diameter in milimeters based on CT image
Measured: Baseline
Aortic annulus area
Aortic annulus area in squared milimeters based on CT image
Measured: Baseline
Aortic annulus perimeter
Aortic annulus perimeter in milimeters based on CT image
Measured: Baseline
Ilio-femoral artery diameter
Ilio-femoral artery diameter in milimeter based on CT image
Measured: Baseline
Neutrophils measured using whole blood count
This measurement is used to compute ratio of cell types using whole blood count
Measured: Baseline
Monocytes measured in whole blood count
Number of monocytes identified in blood sample using automatic whole blood count. It is used to compute cell type ratio.
Measured: Baseline
Lymphocytes measured using whole blood count
This measurement is used to compute ratio of cell types using whole blood count
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Olasinska-Wisniewska, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258706
- Sponsor's protocol ID
- 2025_538
- Acronym
- DIVER-TAVI
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hakgor A, Dursun A, Kahraman BC, Yazar A, Savur U, Akhundova A, Olgun FE, Arman ME, Boztosun B. Prognostic impact of main pulmonary artery to ascending aorta diameter ratio in patients with severe aortic stenosis underwent transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2024 Apr;103(5):782-791. doi: 10.1002/ccd.31000. Epub 2024 Feb 28.
PubMed 38415894Yang Y, Richter R, Halfmann MC, Graafen D, Hell M, Vecsey-Nagy M, Laux G, Kavermann L, Jorg T, Geyer M, Varga-Szemes A, Emrich T. Prospective ECG-gated High-Pitch Photon-Counting CT Angiography: Evaluation of measurement accuracy for aortic annulus sizing in TAVR planning. Eur J Radiol. 2024 Sep;178:111604. doi: 10.1016/j.ejrad.2024.111604. Epub 2024 Jul 6.
PubMed 38996738Schafer M, Glotzbach JP, Sharma V, Tandar A, Welt FG, L Goodwin M, Smego D, Selzman CH, Pereira SJ. Aortic shape and diameter variations are predictive of short-term complications in transcatheter aortic valve replacement. Int J Cardiovasc Imaging. 2025 May;41(5):955-965. doi: 10.1007/s10554-025-03381-2. Epub 2025 Mar 29.
PubMed 40156693