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RecruitingTranscatheter Aortic Valve Replacement

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Wake Forest University Health Sciences

You may qualify if…

  • ✓ Patient age 18 or older
  • ✓ Transfemoral transcatheter aortic valve replacement (TAVR)
  • ✓ Implantation of CoreValve replacement valve
  • ✓ Access using 14 French sheaths
  • ✓ English speaking

You may not qualify if…

  • ✕ 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.
  • ✕ Body Composition: Patients with BMI \>35
  • ✕ Cardiac Vasculature: Patients with excess calcification of vessels as determined by echocardiography and/or CT angiography
  • ✕ 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.

Where it's recruiting

Wisconsin

Milwaukee

Source: ClinicalTrials.gov · NCT06871774 · last updated 2026-06-25

Comparison of Single vs. Dual Perclose Devices for Large-Bore Access C · TrialPath