Clinical and cardiopulmonary predictors of functional recovery and complications after transcatheter aortic valve implantation: Protocol of a prospective interventional study

Abstract

Introduction Transcatheter Aortic Valve Implantation (TAVI) has emerged as a less invasive alternative to surgical aortic valve replacement, especially for high-risk patients. While TAVI is expected to improve symptoms and functional status, clinical recovery is often heterogeneous, and subjective assessments may not fully capture the degree of improvement. To our knowledge, the changes in functional capacity following TAVI have not been well explored using cardiopulmonary exercise testing (CPET).The study aims to characterise mid-term changes in exercise tolerance after TAVI and identify clinical and functional predictors of improvement in exercise capacity and complications after TAVI. Methods and analysis A total of 161 patients with severe aortic stenosis scheduled for TAVI will be prospectively enrolled across three expert centres. Each will undergo clinical assessment and incremental CPET within two weeks before and four to six weeks after the procedure. The primary outcome is a change in VO₂ peak and VO₂ at the anaerobic threshold. Secondary outcomes include exploratory associations between baseline characteristics and observed changes in functional capacity, quality of life and complications. Ethics and dissemination The bioethics committee of the Hospital Clínic de Barcelona, Spain, approved this protocol (HCB/2024/0782). All the participating centres obtained local approval prior to patient recruitment. The findings will be published in a peer-reviewed journal and submitted to relevant conferences. Trial registration ClinicalTrials.gov NCT06833762 (registered 10th of March 2025).