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Quality of Life After Transcatheter Aortic Valve Implantation

Quality of Life After Transcatheter Aortic Valve Implantation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07798713
Acronym
TAVI-QoL
Enrollment
200
Registered
2026-09-01
Start date
2026-08-26
Completion date
2029-01-01
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Aortic Stenosis, Heart Failure, TAVI(Transcatheter Aortic Valve Implantation)

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Kansas City Cardiomyopathy QuestionnaireBaseline (before TAVI) to 1-3 months after TAVIChange 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.

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORAshkan Eftekhari, MD PhD

Aalborg University Hospital Dept. of Cardiology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026