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

NCT06871774 | Recruiting FDA Device

• 1 other identifier: IRB00124842
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

aortic valve diseases; Perclose device; arteriotomy

Outcome Measures

Primary Outcomes (4)

• Number of Patients With Vascular Complications

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

  Day 5 post-procedure

• Number of Patients With Life-threatening bleeding

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

  Hour 24 post-procedure

• Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition

  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.

  Hour 24 post-procedure

• Time to Hemostasis

  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.

  1 hour post procedure

Secondary Outcomes (4)

• Additional Closure Device Use

  Hour 24 post-procedure

• In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions

  Day 5 post-procedure

• Number of Patients With Limb Ischemia Related to TAVR During Index Admission

  Day 5 post-procedure

• Limb Ischemia Related to TAVR

  Day 30 post-procedure

Study Arms (2)

Single Device

EXPERIMENTAL

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.

Device: Single Perclose Pro vascular closure device

Two device

ACTIVE COMPARATOR

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.

Device: Dual Perclose vascular closure device

Interventions

Dual Perclose vascular closure device DEVICE

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

Two device

Single Perclose Pro vascular closure device DEVICE

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

Single Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Suhail Q Allaqaband, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suhail Q Allaqaband, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)