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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIVER-TAVI Registry - Demographic and Interpopulation Variations in Evaluation and Results of TAVI
- ClinicalTrials.gov ID
- NCT07258706
- Acronym / sponsor ID
- DIVER-TAVI / 2025_538
- Conditions
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Computed Tomography, Inflammatory Response During Cardiac Surgery, Inflammation
- Keywords
- Aortic stenosis, transcatheter aortic valve implantation, TAVI, Computed Tomography, Inflammation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with aortic stenosis qualified for TAVI | – | Diagnostic Test: laboratory biomarker analysis, Diagnostic Test: Computed tomography of aortic root and aortaAll consecutive patients with severe aortic stenosis qualified for TAVI according to current guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients qualified for TAVI will be included in the analysis and compared in subpopulations.
Key inclusion criteria (1 listed)
- Severe aortic stenosis qualified for TAVI
Key exclusion criteria (1 listed)
- Active infection (chronic inflammatory disease or neoplasm is not an exclusion criterion, however, will be considered in the laboratory analysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysisResults 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 | Patients with aortic stenosis qualified for TAVI |
| Computed tomography of aortic root and aortaResults of CT analysis performed as a routine diagnostic examination in the pre-procedural period will be recorded. | Diagnostic test | Patients with aortic stenosis qualified for TAVI |
Primary outcome
Aortic annulus diameter
Time frame: Baseline
Aortic annulus diameter in milimeters based on CT image
Aortic annulus area
Time frame: Baseline
Aortic annulus area in squared milimeters based on CT image
Aortic annulus perimeter
Time frame: Baseline
Aortic annulus perimeter in milimeters based on CT image
Ilio-femoral artery diameter
Time frame: Baseline
Ilio-femoral artery diameter in milimeter based on CT image
Neutrophils measured using whole blood count
Time frame: Baseline
This measurement is used to compute ratio of cell types using whole blood count
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.
Lymphocytes measured using whole blood count
Time frame: Baseline
This measurement is used to compute ratio of cell types using whole blood count
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 38415894Hakgor 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.
- Background: PubMed 38996738Yang 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.
- Background: PubMed 40156693Schafer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Olasinska-Wisniewska principal investigator
Poznan University of Medical Sciences
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Poland, Serbia, Thailand, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic annulus diameter (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07258706, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.