Quality of Life Improvement After Transcatheter Aortic Valve Implantation (TAVI) in the UK: A Prospective 1-Year Study (QualiTAVI-UK Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement of QoL
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
Ayman Helal
Professor
University Hospital Plymouth NHS Trust