Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
Wake Forest University Health Sciences
Summary
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.
Description
This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient age 18 or older * Transfemoral transcatheter aortic valve replacement (TAVR) * Implantation of CoreValve replacement valve * Access using 14 French sheaths * English speaking Exclusion Criteria: * Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian access or transapical access. * Planned Surgical Cut-Down: Patients planned for surgical cut-down procedures rather than percutaneous access. * Vascular Access Complications: Patients with known vascular complications at the fem…
Interventions
- DeviceSingle Perclose Pro vascular closure device
Use of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath.
- DeviceDual Perclose vascular closure device
Use of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath.
Location
- Aurora St. Luke's Medical CenterMilwaukee, Wisconsin