Study Comparing Safety of Transcatheter Aortic Valve Implantation TAVI in Hospitals With and Without On-site Cardiac Surgery for Severe Aortic Stenosis

What this Trial Is About

This research evaluates whether transcatheter aortic valve implantation TAVI can be safely and effectively performed in hospitals without on-site cardiac surgery for patients with severe symptomatic aortic stenosis. The study compares outcomes between centers without on-site cardiac surgery and those with such facilities, focusing on clinical results one year after the procedure. It builds on earlier findings that suggest selected patients may have safe access to TAVI even without immediate surgical backup, given proper safeguards and experienced operators. Participants will be randomly assigned to receive TAVI either in a center lacking on-site cardiac surgery but equipped with experienced operators, advanced imaging, and rapid transfer protocols, or in a center with on-site cardiac surgery. The procedure will be performed according to current guidelines and local standards by skilled TAVI operators. Both study arms involve the same procedure but differ in the setting, allowing assessment of safety and effectiveness in these different hospital environments. During the study, participants will undergo thorough evaluations before the procedure, including clinical, imaging, and laboratory tests to confirm eligibility. After the procedure and hospital discharge, they will be followed for one year to monitor clinical events such as death, stroke, and hospitalizations related to the procedure or valve. An independent committee will review clinical events while patient safety is overseen by a monitoring board, aiming to ensure reliable and unbiased assessment of outcomes.

TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery