The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure: A Prospective, Multicenter, Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating vascular closure techniques for patients with severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (TAVR). The study compares the use of a single versus double Perclose Proglide device to manage the access site, which is crucial to reduce vascular complications that can lead to serious outcomes such as bleeding, transfusions, and kidney failure. This randomized controlled trial aims to determine if using a single device offers clinical benefits alongside reduced procedural cost and time. Participants will be randomly assigned to receive either a single or double Perclose Proglide device during their TAVR procedure for large bore arteriotomy site closure. The Perclose system uses a "preclosure" technique where sutures are placed before expanding the arterial access site to secure closure after valve delivery. The study is open-label and conducted across multiple centers with oversight by an independent data coordinating center. During the study, patients will be monitored in the hospital and followed for 30 days to assess vascular complications and related outcomes, including bleeding, need for additional procedures, device failure, and mortality. Researchers will evaluate the time to achieve hemostasis and length of hospital stay. Participants will have planned follow-up evaluations, and data on safety and efficacy outcomes will be collected throughout the trial period.

Comparison of a Single Versus Double Perclose Technique for TAVR