Quality of Life After Transcatheter Aortic Valve Implantation

NCT07798713 | Active Not Recruiting DMC

• 1 other identifier: 126656
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Kansas City Cardiomyopathy Questionnaire

  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.

  Baseline (before TAVI) to 1-3 months after TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients undergoing transcatheter aortic valve implantation in Western Denmark. Patients will be included prospectively and followed from baseline assessment before TAVI to clinical follow-up after the procedure. Patient-reported health status will be assessed using the Kansas City Cardiomyopathy Questionnaire and combined with clinical, echocardiographic, anatomical, and procedural data obtained from patient records.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Department of Cardiology Aalborg University Hospital

Gistrup, 9260, Denmark

Location

Related Publications (1)

• Al-Azizi, K., Abo Hajar, M. B., Pickering, T., Moubarak, G., Dorton, C. W., McCullough, K. A., Ladner, J., Elias, M., Parro, C., McCoy, S. L., Saeed, U., Ma, T.-W., Hale, S., Gupta, S., Harrington, K. B., Schaffer, J. M., Mohiuddin, A., Brinkman, W. T., Alsaid, A., … Mack, M. J. (2026). Impact of Measured and Predicted Patient-Prosthesis Mismatch on Quality of Life Following Transcatheter Aortic Valve Implantation. Structural Heart, 10(1). https://doi.org/10.1016/j.shj.2025.100759 Arnold, S. V, Spertus, J. A., Vemulapalli, S., Li, Z., Matsouaka, R. A., Baron, S. J., Vora, A. N., Mack, M. J., Reynolds, M. R., Rumsfeld, J. S., & Cohen, D. J. (2017). Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population: A report from the STS/ACC transcatheter valve therapy registry. JAMA Cardiology, 2(4), 409-416. https://doi.org/10.1001/jamacardio.2016.5302 Cabrucci, F., Baudo, M., Yamashita, Y., Dokollari, A., Sicouri, S., & Ramlawi, B. (2024). Short and Long-Term Outcomes of Transcatheter Aortic Valve Implantation in the Small Aortic Annulus: A Systematic Literature Review. In Journal of Personalized Medicine (Vol. 14, Number 9). Multidisciplinary Digital Publishing Institute (MDPI). https://doi.org/10.3390/jpm14090937 Capodanno, D., Petronio, A. S., Prendergast, B., Eltchaninoff, H., Vahanian, A., Modine, T., Lancellotti, P., Sondergaard, L., Ludman, P. F., Tamburino, C., Piazza, N., Hancock, J., Mehilli, J., Byrne, R. A., Baumbach, A., Kappetein, A. P., Windecker, S., Bax, J., & Haude, M. (2017). Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: A consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal, 38(45), 3382-3390. https://doi.org/1

  BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Failure; Angina Pectoris

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Myocardial Ischemia; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashkan Eftekhari, MD PhD

  Aalborg University Hospital Dept. of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant MD PhD

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 1, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

DK (1)