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Clinical Trials in Denmark / NCT07798713
Active, not recruiting Observational

Quality of Life After Transcatheter Aortic Valve Implantation

NCT07798713 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aalborg University Hospital
Phase
Observational
Started
2026-08-26
Last updated
2026-09-01

Condition(s) studied

Aortic StenosisHeart FailureAngina PectorisTAVI(Transcatheter Aortic Valve Implantation)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Kansas City Cardiomyopathy Questionnaire — 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.

Trial sites (1)

FacilityCityRegionStatus
Department of Cardiology Aalborg University Hospital Gistrup Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07798713 on ClinicalTrials.gov ↗ ← All trials in Denmark