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

NCT07193004 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-09-30

No results posted yet for this study

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

Interventions

BEHAVIORAL

Quality of Life

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.

Sponsors & Collaborators

  • University Hospital Plymouth NHS Trust

    lead OTHER

Principal Investigators

  • Ayman Helal, MD Cardiology · University Hospitals Plymouth NHS Trust

  • Ayman Helal, MD Cardiology · University Hospitals Plymouth NHS Trust

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-10-30
Completion
2027-02-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193004 on ClinicalTrials.gov