RecruitingNCT06871774

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

Wake Forest University Health SciencesOne US siteView on ClinicalTrials.gov

AI Description

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.

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Who can join
adult, older adult
Participants
300
Expected completion
2027-06
Funded by
other

Conditions studied

Transcatheter Aortic Valve Replacement

What is being tested

  • DEVICE: Dual Perclose vascular closure device
  • DEVICE: Single Perclose Pro vascular closure device

What it measures

  • Number of Patients With Life-threatening bleeding, Number of subjects in each group experiencing any bleeding event related to the TAVR procedure that is life-threatening within 24 hours post-procedure., Hour 24 post-procedure
  • Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition, Number of subjects in each group experiencing bleeding complications related to the TAVR procedure that do not meet the criteria for life-threatening bleeding but still result in significant clinical concern within 24 hours of the index procedure., Hour 24 post-procedure
  • Number of Patients With Vascular Complications, Number of subjects in each group experiencing major or minor vascular complications directly related to the TAVR procedure occurring during the index hospitalization., Day 5 post-procedure
  • Time to Hemostasis, For each subject, time elapsed from initial deployment of the initial one or two Perclose devices (depending on assigned group) to complete hemostasis of the femoral access site. Measured in seconds., 1 hour post procedure

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Aurora St. Luke's Medical Center

Milwaukee, WI

Data Sources and Methodology

Registry entry updated 2026-06-25

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