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

Launched by BAYLOR RESEARCH INSTITUTE · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at different methods for closing the small incision made in the thigh after a procedure called Transcatheter Aortic Valve Replacement (TAVR). The researchers want to compare two techniques: using two ProGlide devices versus one ProGlide device and another closure device called Angioseal. The goal is to see which method is safer and has fewer complications after the surgery.

To participate in this study, you need to be at least 18 years old and scheduled to have TAVR through a femoral artery in your leg. You also need to be able to give your permission for joining the study. However, people who have had previous surgeries on the femoral artery, those with certain medical conditions, or those under 18 cannot participate. If you join the study, you will be monitored closely after your procedure to ensure your safety and help researchers understand the best way to close the incision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old
• • Planned to undergo transcatheter aortic valve replacement via femoral access
• • Able to provide written informed consent prior to study participation
• Exclusion Criteria:
• • Non-femoral access
• • Previous repair or intervention of the common femoral artery
• • Previous pseudoaneurysm of the common femoral artery
• • Children below 18 years, prisoners, and patients who are unable to provide consent are excluded.
• • In another research study that has not granted permission to dual-enroll.