Aortic StenosisTAVI-QoLNCT07798713
Quality of Life After Transcatheter Aortic Valve Implantation
An observational study of Aortic Stenosis and Heart Failure, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Heart Failure, Angina Pectoris
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Aug 2026to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology Aalborg University Hospital
Gistrup, 9260
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Aortic Stenosis, Heart Failure, Angina Pectoris, TAVI(Transcatheter Aortic Valve Implantation)
- Medical subject headings
- Aortic Valve Stenosis, Heart Failure, Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before TAVI) to 1-3 months after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start26 Aug 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashkan Eftekhari, Aalborg University Hospital
- Investigators
- Ashkan Eftekhari, MD PhD, Principal investigator, Aalborg University Hospital Dept. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798713
- Sponsor's protocol ID
- 126656
- Acronym
- TAVI-QoL
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT07798713
- Acronym / sponsor ID
- TAVI-QoL / 126656
- Conditions
- Aortic Stenosis, Heart Failure, Angina Pectoris, TAVI(Transcatheter Aortic Valve Implantation)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- BackgroundAl-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
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashkan Eftekhari, MD PhD principal investigator
Aalborg University Hospital Dept. of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Heart Failure, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kansas City Cardiomyopathy Questionnaire (time frame: Baseline (before TAVI) to 1-3 months after TAVI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07798713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.