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
Trial Information
Current as of July 22, 2025
Recruiting
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.
About Baylor Research Institute
Baylor Research Institute (BRI) is a leading clinical research organization affiliated with Baylor Scott & White Health, dedicated to advancing medical knowledge and improving patient care through innovative research initiatives. With a focus on translational medicine, BRI conducts a wide range of clinical trials across various therapeutic areas, including cardiovascular, oncology, and neurology. The institute is committed to fostering collaborative partnerships with academic institutions, industry leaders, and healthcare professionals to enhance the development of novel therapies and interventions. Through rigorous scientific methodology and ethical standards, Baylor Research Institute strives to contribute significantly to the advancement of healthcare and to provide patients with access to cutting-edge treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Plano, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported