Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06871774

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

Led by Wake Forest University Health Sciences · Updated on 2026-01-21

300

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient age 18 or older
  • Undergoing transfemoral transcatheter aortic valve replacement (TAVR)
  • Implantation of CoreValve replacement valve
  • Access using 14 French sheaths
  • English speaking
Not Eligible

You will not qualify if you...

  • Undergoing TAVR via alternative access routes such as subclavian or transapical access
  • Planned for surgical cut-down procedures instead of percutaneous access
  • Known vascular complications at the femoral access site, including residual hematoma or recent femoral arteriotomy/venotomy within past 10 days
  • History of significant vascular complications or prior intravascular closure device use within previous 30 days
  • Small femoral arteries or veins (less than 5 mm in diameter)
  • Access sites located in vascular grafts
  • Body mass index (BMI) greater than 35
  • Excess vessel calcification as determined by echocardiography or CT angiography
  • Active systemic or cutaneous infection or inflammation near the groin
  • Known bleeding diathesis, coagulopathy, hypercoagulability, or platelet count below 100,000 cells/mm³
  • Pre-existing immunodeficiency or chronic use of high-dose systemic steroids
  • Severe co-existing illnesses with life expectancy less than 12 months
  • Unable to walk at least 20 feet without assistance
  • Use of low molecular weight heparin (LMWH) within 8 hours before or after procedure
  • Pregnant or lactating women
  • Receiving Edwards Sapien valve
  • Contraindications for use of Perclose device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215

Actively Recruiting

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Research Team

S

Suhail Q Allaqaband, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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