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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for closing the access point in the leg after a procedure called Transcatheter Aortic Valve Replacement (TAVR). Specifically, it will compare using one Perclose device to the usual method of using two devices. The main goals of the study are to see how quickly bleeding stops with each method and to check for any complications that might arise.

To participate in this trial, you need to be at least 18 years old and undergoing TAVR with a specific type of valve called the CoreValve. You should also have an access point in your leg that can accommodate a 14 or 16 French sheath. However, there are some important exclusions, such as if you have certain vascular issues, are pregnant, or are unable to walk a short distance without help. If you join the study, you can expect to be monitored closely for any complications and your recovery will be part of the research to help improve future care for patients undergoing TAVR.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient age 18 or older
• • Transfemoral transcatheter aortic valve replacement (TAVR)
• • Implantation of CoreValve replacement valve
• • Access using 14 or 16 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 femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days.
• • Arterial or Venous Issues: Patients with small femoral arteries or veins (\<5 mm in diameter), patients with access sites located in vascular grafts.
• • Infection or Inflammation: Active systemic or cutaneous infection or inflammation in the vicinity of the groin.
• • Coagulation and Hematological Disorders: Known history of bleeding diathesis, coagulopathy, hypercoagulability, or platelet count \<100,000 cells/mm³. Pre-existing immunodeficiency disorder or chronic use of high-dose systemic steroids.
• • Severe Morbidity: Severe co-existing morbidities with a life expectancy less than 12 months.
• • Mobility Issues: Patients unable to routinely walk at least 20 feet without assistance.
• • Recent Anticoagulation: Use of low molecular weight heparin (LMWH) within 8 hours before or after the procedure.
• • Pregnancy and Lactation: Pregnant or lactating women.
• • Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
• • Contraindications: Patients with contraindications for the use of Perclose device.