Demographic and Interpopulation Variations in Evaluation and Results of TAVI
NCT ID: NCT07258706
Last Updated: 2025-12-02
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
800 participants
OBSERVATIONAL
2025-01-01
2028-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with aortic stenosis qualified for TAVI
All consecutive patients with severe aortic stenosis qualified for TAVI according to current guidelines
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Poznan University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Anna Olasinska-Wisniewska
Role: PRINCIPAL_INVESTIGATOR
Poznan University of Medical Sciences
Locations
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San Bortolo's Hospital, Division of Cardiac Surgery and Division of Cardiology, Vicenza, Italy
Vicenza, , Italy
Poznan University of Medical Sciences
Poznan, , Poland
Institute for Cardiovascular Diseases of Vojvodina, Serbia University of Novi Sad
Novi Sad, , Serbia
King Chulalongkorn Memorial Hospital, Bangkok, Thailand
Bangkok, , Thailand
Ankara Bilkent City Hospital, Ankara, Türkiye
Ankara, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
Other Identifiers
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2025_538
Identifier Type: -
Identifier Source: org_study_id
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