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OpenTrials
Active, not recruiting

NCT Number: NCT07798713

Quality of Life After Transcatheter Aortic Valve Implantation

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Undergoing transcatheter aortic valve implantation (TAVI)
  • TAVI performed within the study recruitment period
  • Available baseline KCCQ assessment
  • Able to participate in follow-up assessment

Exclusion criteria

  • Severe cognitive impairment preventing completion of the KCCQ
  • Language barrier preventing completion of the KCCQ
  • Severe illness or clinical condition preventing participation in follow-up

Treatment and study plan

Primary outcomes

  1. Kansas City Cardiomyopathy Questionnaire

    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.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Acronym: TAVI-QoL

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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