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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Transcatheter Aortic Valve Replacement

Treatments: Device: Single Perclose Pro vascular closure device; Device: Dual Perclose vascular closure device

Study type: Interventional

Funder types: Other

Identifiers

NCT06871774

IRB00124842

Details and patient eligibility

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.

Full description

This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-closure strategy arm.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Single Device

Experimental group

Description:

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.

Treatment:

Device: Single Perclose Pro vascular closure device

Two device

Active Comparator group

Description:

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.

Treatment:

Device: Dual Perclose vascular closure device