The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral access).
The main questions it aims to answer are:
Does using a single suture device lower the rate of access-related vascular complications compared to using a hybrid combination of a suture device and a plug-based closure device? How do the two closure strategies compare regarding bleeding complications, procedure time, and time to complete vessel sealing?
Researchers will compare a single-suture closure strategy to a hybrid closure strategy (one suture plus one plug-based device) to see if using a single suture reduces vessel-related complications and improves patient safety after TAVI.
Participants will:
Undergo standard pre-procedure screening and TAVI via the main artery in the leg as part of routine medical care.
Receive an initial single-suture placement before the large TAVI delivery system is inserted.
Be evaluated after sheath removal for initial bleeding control; qualifying participants will then be randomly assigned (1:1) to either receive no additional device (single suture group) or receive a plug-based closure device (hybrid group).
Have their heart and access site monitored during hospitalization, including laboratory checks and imaging prior to discharge.
Complete a 72-hour safety and complication evaluation.