Recruiting

Perclose vs. Two Devices

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06871774

Conditions

Transcatheter Aortic Valve Replacement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single Perclose Pro vascular closure device

Dual Perclose vascular closure device

Study Details

Brief summary:

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

Transcatheter Aortic Valve Replacement

Study ID

NCT06871774

Start date

Jun 16, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Device

A single Perclose device will be used for pre-closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis.

active comparator: Two device

Two Perclose devices will be used for pre-closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis.

Interventions

Single Perclose Pro vascular closure device

Use of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath.

Dual Perclose vascular closure device

Use of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath.

Primary outcome measure

  • Number of Patients With Vascular Complications [ Time Frame: Day 5 post-procedure ]
  • Number of Patients With Life-threatening bleeding [ Time Frame: Hour 24 post-procedure ]
  • Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition [ Time Frame: Hour 24 post-procedure ]
  • Time to Hemostasis [ Time Frame: 1 hour post procedure ]

Central Contacts and Locations

Central contacts

Suhail Q Allaqaband, MD

414-649-3491suhail.allaqaband@aah.org

Locations

Aurora St. Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Suhail Q Allaqaband, MD

414-649-3491suhail.allaqaband@aah.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • aortic valve diseases
  • Perclose device
  • arteriotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-25.