Frailty Response in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (FRAIL-AS Response Trial): Study Protocol for a Cluster Randomised Controlled Trial

BACKGROUND and (2) an Implementation Strategy informed by the Theoretical Domains Framework, incorporating meetings to determine local barriers and solutions, clinician education, local clinical champions, audit and feedback, action plans and remote facilitation. The primary outcome is the proportion of frail AS patients scheduled for TAVI receiving nutritional screening after frailty identification. Secondary outcomes are patient outcomes (as per the Valve Academic Research Consortium 3 endpoints), processes of care (frailty information provision, GP notifications, referrals for cardiac rehabilitation and geriatrician review) and implementation outcomes (intervention acceptability, feasibility and fidelity). CONCLUSIONS: The FRAIL-AS Response Trial will determine whether addressing frailty in older adults with AS undergoing TAVI enhances evidence-based care, reduces complications, and improves patient outcomes. If effective, the FRAIL-AS Response Program may provide a scalable, evidence-based model for managing patients with heart valve disease and frailty undergoing transcatheter procedures.