Single versus Dual Perclose Device Closure for Large-Bore Femoral Access in TAVR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center randomized trial will enroll patients undergoing transfemoral TAVR with CoreValve and 14 French sheaths and randomize them equally to pre-closure with either a single Perclose device or the standard two-device approach. The primary outcome is time to hemostasis, with secondary outcomes including access-site bleeding, vascular complications, and need for additional interventions. Procedural timing, device performance, and complication rates will be collected and compared between the two arms. The goal is to determine whether a single-device pre-closure strategy can streamline care without increasing risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Where it's running

• Aurora St. Luke's Medical Center
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Suhail Q Allaqaband, MD — Wake Forest University Health Sciences
• Study coordinator: Suhail Q Allaqaband, MD
• Email: suhail.allaqaband@aah.org
• Phone: 414-649-3491

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.