Demographic and Interpopulation Variations in Evaluation and Results of TAVI

NCT07258706 | Enrolling By Invitation

• 1 other identifier: 2025_538
• Study Type: observational
• Target: 800
• Locations: 5 countries
• Sites: 5

Brief 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.

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

Outcome Measures

Primary Outcomes (7)

• Aortic annulus diameter

  Aortic annulus diameter in milimeters based on CT image

  Baseline

• Aortic annulus area

  Aortic annulus area in squared milimeters based on CT image

  Baseline

• Aortic annulus perimeter

  Aortic annulus perimeter in milimeters based on CT image

  Baseline

• Ilio-femoral artery diameter

  Ilio-femoral artery diameter in milimeter based on CT image

  Baseline

• Neutrophils measured using whole blood count

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

  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.

  Baseline

• Lymphocytes measured using whole blood count

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

  Baseline

Study Arms (1)

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; Diagnostic Test: Computed tomography of aortic root and aorta

Interventions

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

Patients with aortic stenosis qualified for TAVI

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.

Patients with aortic stenosis qualified for TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Severe aortic stenosis qualified for TAVI

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (5)

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

Vicenza, Italy

Location

Poznan University of Medical Sciences

Poznan, 61-848, Poland

Location

Institute for Cardiovascular Diseases of Vojvodina, Serbia University of Novi Sad

Novi Sad, Serbia

Location

King Chulalongkorn Memorial Hospital, Bangkok, Thailand

Bangkok, Thailand

Location

Ankara Bilkent City Hospital, Ankara, Türkiye

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 38415894 BACKGROUND

• Yang 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.

  PMID: 38996738 BACKGROUND

• Schafer 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.

  PMID: 40156693 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Inflammation

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Olasinska-Wisniewska

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-09

Locations

SE (1); IT (1); PL (1); TH (1); TU (1)