Randomized Study Comparing Single Versus Dual Perclose Devices for Blood Vessel Closure After Transcatheter Aortic Valve Replacement TAVR

What this Trial Is About

Researchers are evaluating the use of one versus two Perclose devices for closing the vascular access site during Transcatheter Aortic Valve Replacement TAVR procedures. This randomized trial aims to compare the time it takes to stop bleeding and the occurrence of complications between the single-device and dual-device pre-closure approaches. The study focuses on patients undergoing TAVR with a CoreValve replacement valve and 14 French sheath access. Participants will be randomly assigned to receive either a single Perclose device or two Perclose devices for pre-closure of their vascular access site. Manual pressure and additional devices may be used as needed to achieve hemostasis in both groups. The trial is conducted at a single center and enrolls an equal number of patients in each pre-closure group to assess the performance and safety of these techniques. During the study, patients will be monitored for vascular and bleeding complications at specific time points after the procedure, including assessments at 1 hour, 24 hours, 5 days, and 30 days post-procedure. Researchers will evaluate time to hemostasis and the need for additional closure devices. Safety will be monitored by tracking serious vascular complications, limb ischemia, and bleeding events. Participation involves follow-up visits and assessments to measure these outcomes, with the total study duration extending up to 30 days post-procedure.

Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR