Department of Cardiology Aalborg University Hospital
Gistrup, 9260, Denmark
NCT Number: NCT07798713
This observational cohort study investigates whether hemodynamic improvements following transcatheter aortic valve implantation (TAVI) are associated with improvements in patient-reported quality of life among patients in Western Denmark.
Quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire before TAVI and at follow-up. Changes in quality of life will be evaluated in relation to changes in mean transvalvular gradient, left ventricular ejection fraction, and New York Heart Association functional class. Clinical data will be obtained from patient records.
Secondary analyses will explore whether patient characteristics, comorbidities, anatomical factors, and procedural characteristics are associated with quality-of-life improvement following TAVI.
The study aims to improve understanding of the relationship between objective treatment outcomes and patients' perceived health status after TAVI.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Gistrup, 9260, Denmark
Transcatheter aortic valve implantation (TAVI) results in substantial hemodynamic improvement in patients with severe aortic stenosis, including reduction in transvalvular pressure gradient and left ventricular afterload. However, objective improvements in valve hemodynamic may not necessarily correspond to improvements in patients' perceived health status and quality of life.
This observational cohort study will examine the relationship between changes in patient-reported health status and changes in objective and functional clinical parameters following TAVI. Patient-reported health status will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) used as the primary patient-reported outcome measure.
Changes in KCCQ from baseline to follow-up will be evaluated in relation to changes in mean transvalvular gradient and left ventricular ejection fraction as well as changes in New York Heart Association functional class.
Secondary analyses will investigate factors potentially associated with variation in quality-of-life improvement after TAVI. These include demographic and clinical characteristics such as age, sex, weight, type 2 diabetes mellitus, ischemic heart disease, hypertension, atrial fibrillation, and chronic kidney disease. Anatomical and procedural characteristics, including aortic annulus size, transcatheter valve size, pre- and post-dilatation, and procedural complications, will also be evaluated.
Particular attention will be given to whether sex and anatomical characteristics are associated with differences in the relationship between hemodynamic improvement and patient-reported outcomes.
The study combines prospectively collected KCCQ data with clinical, echocardiographic, anatomical, and procedural information obtained from patient records. By examining patient-reported outcomes alongside conventional measures of treatment response, the study seeks to characterize potential discordance between objective improvement following TAVI and improvement experienced by the patient.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (before TAVI) to 1-3 months after TAVI
Change in patient-reported health status from baseline to follow-up after TAVI, assessed using the Kansas City Cardiomyopathy Questionnaire. Scores range from 0 to 100, with higher scores indicating better health status. The outcome will be calculated as the difference between follow-up and baseline KCCQ scores.
Aalborg University Hospital
Other
Acronym: TAVI-QoL
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