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.
Inclusion Criteria:
Exclusion Criteria:
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Due to the nature of the intra-operative vascular closure procedure, the operator (Investigator) and immediate interventional team (Care Providers) cannot be masked to device assignment during the TAVI procedure.
Single suture-based vascular closure device (VCD) pre-placed prior to sheath insertion.
Single suture-based VCD combined with an extravascular plug-based VCD (Angio-Seal®)
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement
Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure