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.

NCT Number	NCT07193004
Lead Sponsor	University Hospital Plymouth NHS Trust
Conditions	TAVI(Transcatheter Aortic Valve Implantation), TAVI, Quality of Life, Mental Health
Enrollment	100 participants
Start Date	2025-11-01
Primary Completion	2026-10-30 (estimated)
Study Completion	2027-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-30