Quality of Life Improvement After TAVI (QualiTAVI-UK Trial)

NCT07193004 | Not Yet Recruiting DMC

• 1 other identifier: 25/CAR/222
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

TAVI(Transcatheter Aortic Valve Implantation); TAVI; Quality of Life; Mental Health

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  30 days post-TAVI (early follow-up to assess recovery and improvement in QoL), and 3 months post-TAVI

Study Arms (1)

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.

Behavioral: Quality of Life

Interventions

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.

Also known as: KCCQ-12, CFS, Mini-MoCA

TAVI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who declined enrollment in this research.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 35275374 BACKGROUND

• Shimura 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.

  PMID: 28302751 BACKGROUND

• Kennon 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.

  PMID: 34810276 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ayman Helal, MD Cardiology

  University Hospitals Plymouth NHS Trust

  STUDY CHAIR

• Ayman Helal, MD Cardiology

  University Hospitals Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayman Helal, MD Cardiology

CONTACT

+447376863806; ayman.helal1@nhs.net

Venkatesan Suresh, MD Cardiology

CONTACT

+447766460037; vsuresh@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)