Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Wisconsin
Aurora St. Luke's Medical Center
RECRUITING
Milwaukee
Contact Information
Primary
Suhail Q Allaqaband, MD
suhail.allaqaband@aah.org
414-649-3491
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2026-07
Participants
Target number of participants: 300
Treatments
Experimental: Single Device
A single Perclose device will be used for pre-closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis.
Active_comparator: Two device
Two Perclose devices will be used for pre-closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences