Single versus Dual Perclose Device Closure for Large-Bore Femoral Access in TAVR
Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
This will test whether using one Perclose device instead of two closes large-bore femoral access faster and with similar or fewer complications in people having transfemoral TAVR.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06871774 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) undergoing transfemoral TAVR with a CoreValve using 14 French sheaths who can consent in English and meet vascular size criteria are the ideal candidates.
Not a fit: Patients with alternative access routes, planned surgical cut-down, small femoral vessels (<5 mm), recent femoral vascular injury, or recent prior intravascular closure-device use are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, a single-device approach could shorten closure time, lower device costs, and reduce access-site complications for TAVR patients.
How similar studies have performed: Observational and small cohort reports suggest single-Perclose closure can be effective in selected cases, but randomized evidence is limited and results are mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milwaukee, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.