TAVI(Transcatheter Aortic Valve Implantation)QualiTAVI-UKNCT07193004
Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)
An observational study of TAVI(Transcatheter Aortic Valve Implantation) and TAVI, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
Transcatheter aortic valve implantation (TAVI) has become an important therapeutic intervention for patients with symptomatic severe aortic stenosis (AS) who are at high surgical risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TAVI(Transcatheter Aortic Valve Implantation), TAVI, Quality of Life
- What is being tested?
- Quality of Life
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2025to 1 Feb 2027
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Who may be able to join
- Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Who cannot join
- Patients who declined enrollment in this research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Quality of Life Improvement After Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK Trial)
Transcatheter aortic valve implantation (TAVI) has become an important therapeutic intervention for patients with symptomatic severe aortic stenosis (AS) who are at high surgical risk. While the clinical outcomes of TAVI are well established, there is limited data on the long-term quality of life (QoL) following the procedure. This prospective study will assess QoL in patients undergoing TAVI at Derriford Hospital, University Hospitals Plymouth, UK. Investigators will employ the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Mini-Montreal Cognitive Assessment (Mini-MoCA) to evaluate both physical and mental health outcomes, supplemented by an analysis of life expectancy estimated by a multidisciplinary team (MDT). Data will be collected at referral, pre-procedural, 30 days, and 3 months post-TAVI. This will be the first prospective trial focused on QoL improvement after TAVI, as all previous studies have been retrospective in nature. The study aims to provide comprehensive insights into the QoL improvements after TAVI, which will guide future clinical decision-making in this population.
Read the detailed description
Study Title uality of Life Improvement after Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK trial)
Study Design This is a prospective, single-center study that will be conducted over 1 year at Derriford Hospital, University Hospitals Plymouth, UK.
Study Participants The study will include all patients undergoing TAVI for severe AS during this period.
Eligibility Criteria Inclusion Criteria: Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Exclusion Criteria: Patients who declined enrollment in this research.
Planned Sample Size More than 100 patients
Follow-up Duration 3 months
Planned Study Period 1 year
Primary Objective This study aims to address the knowledge gap regarding the impact of TAVI on Quality of Life (QoL) Secondary Objective -
- Being tested
- Quality of Life
- Keywords
- Transcatheter aortic valve implantation (TAVI), quality of life, Kansas City Cardiomyopathy Questionnaire, Mini-Montreal Cognitive Assessment (Mini-MoCA), life expectancy, Mental health, Clinical Frailty Scale (CFS)
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of LifeBehavioural
Also called KCCQ-12, CFS, Mini-MoCA
Measures - We will use the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) to assess QoL, Mini-Montreal Cognitive Assessment (Mini-MoCA) to assess cognitive function, the Clinical Frailty Scale (CFS) to assess frailty status, and life expectancy estimation by the heart team to categorize patients as having: 1-2 years expected survival or more than 2 years expected survival (This will allow for an analysis of how life expectancy correlates with QoL improvements after TAVI).
Assessment Timeline - Patients will be assessed at four key time points: at time of referral (baseline assessment), pre-procedure (to assess impact of delay on the patient), 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI (longer-term follow-up to evaluate sustained QoL changes). At each time point, the KCCQ-12, Mini-MoCA, and Clinical Frailty Scale (CFS) will be administered.
| Study group | Role | What they receive |
|---|---|---|
| TAVI | Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure. Receives: Behavioral: Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of QoL
This is defined as improvement in QoL scores from baseline to 3 months post-TAVI. Based on KCCQ-12, a change of 5 points (small but clinically important change), 10 points (moderate-to-large), and 20 points (large-to-very large clinical changes). Based on CFS score, worsened frailty is defined as an increase in CFS score of +4, and improved frailty by a decrease of -2.
Measured: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI
Secondary outcomes (1)
Correlation between life expectancy and QoL improvements
Correlation between life expectancy and QoL improvements using regression analysis. Mental health and cognitive function (Mini-MoCA scores), frailty status (CFS), will be explored as potential mediators of QoL outcomes.
Measured: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TAVI(Transcatheter Aortic Valve Implantation)Studies of the same condition, open and under way.
- 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
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Helal, University Hospital Plymouth NHS Trust
- Investigators
- Ayman Helal, MD Cardiology, Study chair, University Hospital Plymouth NHS TrustAyman Helal, MD Cardiology, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193004
- Sponsor's protocol ID
- 25/CAR/222
- Acronym
- QualiTAVI-UK
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant information related to the study will be shared
Publications
Monnin C, Besutti M, Ecarnot F, Guillon B, Chatot M, Chopard R, Yahia M, Meneveau N, Schiele F. Prevalence and severity of cognitive dysfunction in patients referred for transcatheter aortic valve implantation (TAVI): clinical and cognitive impact at 1 year. Aging Clin Exp Res. 2022 Aug;34(8):1873-1883. doi: 10.1007/s40520-022-02102-2. Epub 2022 Mar 11.
PubMed 35275374Shimura T, Yamamoto M, Kano S, Kagase A, Kodama A, Koyama Y, Tsuchikane E, Suzuki T, Otsuka T, Kohsaka S, Tada N, Yamanaka F, Naganuma T, Araki M, Shirai S, Watanabe Y, Hayashida K; OCEAN-TAVI Investigators. Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement. Circulation. 2017 May 23;135(21):2013-2024. doi: 10.1161/CIRCULATIONAHA.116.025630. Epub 2017 Mar 16.
PubMed 28302751Kennon S, Styra R, Bonaros N, Stastny L, Romano M, Lefevre T, Di Mario C, Stefano P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Luske C, Bramlage P, Frank D. Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire. Open Heart. 2021 Nov;8(2):e001821. doi: 10.1136/openhrt-2021-001821.
PubMed 34810276Gonnah AR, Abdelwahab M, Taylor R, Labib A, Masoud O, Debski M, Abdelaziz HK, Roberts DH. Health-related quality of life following TAVI or cardiac surgery in patients at intermediate and low risk: a systematic review and meta-analysis. Clin Med (Lond). 2023 Nov;23(6):594-605. doi: 10.7861/clinmed.2023-0258.
PubMed 38065591
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Improvement After Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK Trial)
- ClinicalTrials.gov ID
- NCT07193004
- Acronym / sponsor ID
- QualiTAVI-UK / 25/CAR/222
- Keywords
- Transcatheter aortic valve implantation (TAVI), quality of life, Kansas City Cardiomyopathy Questionnaire, Mini-Montreal Cognitive Assessment (Mini-MoCA), life expectancy, Mental health, Clinical Frailty Scale (CFS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 25 Sep 2025 (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.
Transcatheter aortic valve implantation (TAVI) has become an important therapeutic intervention for patients with symptomatic severe aortic stenosis (AS) who are at high surgical risk. While the clinical outcomes of TAVI are well established, there is limited data on the long-term quality of life (QoL) following the procedure. This prospective study will assess QoL in patients undergoing TAVI at Derriford Hospital, University Hospitals Plymouth, UK. Investigators will employ the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and Mini-Montreal Cognitive Assessment (Mini-MoCA) to evaluate both physical and mental health outcomes, supplemented by an analysis of life expectancy estimated by a multidisciplinary team (MDT). Data will be collected at referral, pre-procedural, 30 days, and 3 months post-TAVI. This will be the first prospective trial focused on QoL improvement after TAVI, as all previous studies have been retrospective in nature. The study aims to provide comprehensive insights into the QoL improvements after TAVI, which will guide future clinical decision-making in this population.
Detailed description
Study Title uality of Life Improvement after Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK trial)
Study Design This is a prospective, single-center study that will be conducted over 1 year at Derriford Hospital, University Hospitals Plymouth, UK.
Study Participants The study will include all patients undergoing TAVI for severe AS during this period.
Eligibility Criteria Inclusion Criteria: Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Exclusion Criteria: Patients who declined enrollment in this research.
Planned Sample Size More than 100 patients
Follow-up Duration 3 months
Planned Study Period 1 year
Primary Objective This study aims to address the knowledge gap regarding the impact of TAVI on Quality of Life (QoL) Secondary Objective -
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI | – | Behavioral: Quality of LifePatients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Key inclusion criteria (1 listed)
- Patients who were eligible and accepted for TAVI procedure regardless of the patient's age and informed consent provided by the patient for the TAVI procedure.
Key exclusion criteria (1 listed)
- Patients who declined enrollment in this research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of LifeAlso: KCCQ-12, CFS, Mini-MoCAMeasures - We will use the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) to assess QoL, Mini-Montreal Cognitive Assessment (Mini-MoCA) to assess cognitive function, the Clinical Frailty Scale (CFS) to assess frailty status, and life expectancy estimation by the heart team to categorize patients as having: 1-2 years expected survival or more than 2 years expected survival (This will allow for an analysis of how life expectancy correlates with QoL improvements after TAVI). Assessment Timeline - Patients will be assessed at four key time points: at time of referral (baseline assessment), pre-procedure (to assess impact of delay on the patient), 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI (longer-term follow-up to evaluate sustained QoL changes). At each time point, the KCCQ-12, Mini-MoCA, and Clinical Frailty Scale (CFS) will be administered. | Behavioural | TAVI |
Primary outcome
Improvement of QoL
Time frame: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI
This is defined as improvement in QoL scores from baseline to 3 months post-TAVI. Based on KCCQ-12, a change of 5 points (small but clinically important change), 10 points (moderate-to-large), and 20 points (large-to-very large clinical changes). Based on CFS score, worsened frailty is defined as an increase in CFS score of +4, and improved frailty by a decrease of -2.
1 secondary outcome
Correlation between life expectancy and QoL improvements
Time frame: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI
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 30 Sep 2025.
- Background: PubMed 35275374Monnin C, Besutti M, Ecarnot F, Guillon B, Chatot M, Chopard R, Yahia M, Meneveau N, Schiele F. Prevalence and severity of cognitive dysfunction in patients referred for transcatheter aortic valve implantation (TAVI): clinical and cognitive impact at 1 year. Aging Clin Exp Res. 2022 Aug;34(8):1873-1883. doi: 10.1007/s40520-022-02102-2. Epub 2022 Mar 11.
- Background: PubMed 28302751Shimura T, Yamamoto M, Kano S, Kagase A, Kodama A, Koyama Y, Tsuchikane E, Suzuki T, Otsuka T, Kohsaka S, Tada N, Yamanaka F, Naganuma T, Araki M, Shirai S, Watanabe Y, Hayashida K; OCEAN-TAVI Investigators. Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement. Circulation. 2017 May 23;135(21):2013-2024. doi: 10.1161/CIRCULATIONAHA.116.025630. Epub 2017 Mar 16.
- Background: PubMed 34810276Kennon S, Styra R, Bonaros N, Stastny L, Romano M, Lefevre T, Di Mario C, Stefano P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Luske C, Bramlage P, Frank D. Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire. Open Heart. 2021 Nov;8(2):e001821. doi: 10.1136/openhrt-2021-001821.
- Background: PubMed 38065591Gonnah AR, Abdelwahab M, Taylor R, Labib A, Masoud O, Debski M, Abdelaziz HK, Roberts DH. Health-related quality of life following TAVI or cardiac surgery in patients at intermediate and low risk: a systematic review and meta-analysis. Clin Med (Lond). 2023 Nov;23(6):594-605. doi: 10.7861/clinmed.2023-0258.
- Individual participant dataSharing planned: Yes. Relevant information related to the study will be shared
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
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Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
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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.
Ayman Helal, MD Cardiology study chair
University Hospital Plymouth NHS Trust
Ayman Helal, MD Cardiology principal investigator
University Hospital Plymouth NHS Trust
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 TAVI(Transcatheter Aortic Valve Implantation) and TAVI, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 Sep 2025. 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 United Kingdom. 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?
Contact Ayman Helal, MD Cardiology (+447376863806, ayman.helal1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of QoL (time frame: 30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-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 NCT07193004, which also lists 4 linked publications.
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 30 Sep 2025.