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.
Patient is at least 18 years of age at the time of screening.
Patient is scheduled to undergo elective transcatheter aortic valve implantation (TAVI) via transfemoral arterial access.
Patient is deemed suitable for transfemoral TAVI and large-bore vascular access closure by the local Heart Team.
Patient (or legally authorized representative) provides written informed consent prior to initiating any study-related procedures.
Planned TAVI procedure via non-femoral arterial access (e.g., transapical, transaortic, subclavian/axillary, or carotid access).
Emergency or non-elective TAVI procedure.
Target main femoral artery vessel diameter, calcification, or tortuosity judged unsuitable for standard percutaneous large-bore vascular closure device deployment.
Known active, unresolved local or systemic infection at the planned vascular access site.
University Hospital, Basel, Switzerland
Lead sponsor
University Hospital, Zürich
Collaborator
University Heart Center Freiburg - Bad Krozingen
Collaborator
University Hospital Giessen and Marburg
Collaborator
University Hospital Galway
Collaborator