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Comparing Perclose Devices for TAVR Access Closure

This study is comparing two ways to close the access site in your leg after a Transcatheter Aortic Valve Replacement (TAVR) procedure. TAVR is a minimally invasive heart valve replacement. Researchers want to see if using one Perclose device is as effective as using two Perclose devices to close the small opening made for the TAVR procedure. They will look at how long it takes for bleeding to stop and if there are fewer complications like bleeding or blood vessel problems. You may be able to join if you are 18 or older, having a TAVR with a CoreValve, and speak English. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This is a randomized study, meaning you would be assigned by chance to receive either one or two Perclose devices. The study plans to enroll 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for vascular complications up to 5 days after the procedure. They will also check for bleeding complications within 24 hours after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06871774

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

Recruiting
NAAges 18+InterventionalTreatment
Wake Forest University Health Sciences
~300 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Single Perclose Pro vascular closure deviceDual Perclose vascular closure device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients With Vascular Complications
Measured over Day 5 post-procedure
+3 more outcomes measured

Conditions

Transcatheter Aortic Valve Replacement

Explore related trials

Aortic Valve Disorder

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Suhail Q Allaqaband, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Suhail Q Allaqaband, MD
[email protected]
414-649-3491
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
Severe Morbidity: Severe co-existing morbidities with a life expectancy less than 12 months.
Mobility Issues: Patients unable to routinely walk at least 20 feet without assistance.
Recent Anticoagulation: Use of low molecular weight heparin (LMWH) within 8 hours before or after the procedure.
Pregnancy and Lactation: Pregnant or lactating women.
Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
Contraindications: Patients with contraindications for the use of Perclose device.

What this trial measures

  • Number of Patients With Vascular ComplicationsDay 5 post-procedure

    Number of subjects in each group experiencing major or minor vascular complications directly related to the TAVR procedure occurring during the index hospitalization.

  • Number of Patients With Life-threatening bleedingHour 24 post-procedure

    Number of subjects in each group experiencing any bleeding event related to the TAVR procedure that is life-threatening within 24 hours post-procedure.

  • Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening ConditionHour 24 post-procedure

    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.

  • Time to Hemostasis1 hour post procedure

    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.