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NCT Number: NCT07193004

Quality of Life Improvement After TAVI (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.

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Key information

Conditions

TAVI(Transcatheter Aortic Valve Implantation) Behavior Mental Health Personal Satisfaction Psychological Well-Being Quality of Life TAVI

Sex eligibility

All sexes

Study type

Observational

Primary location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

About this study

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 -

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

quality of life

Behavioral

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.

Other names: KCCQ-12, CFS, Mini-MoCA

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayman Helal, MD Cardiology

CONTACT

[email protected]

+447376863806

Venkatesan Suresh, MD Cardiology

CONTACT

[email protected]

+447766460037

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study title

Quality of Life Improvement After Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK Trial)

Acronym: QualiTAVI-UK

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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