Clinical trial NCT06871774: Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
Official title: Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcatheter Aortic Valve Replacement
Keywords: aortic valve diseases
Perclose device
arteriotomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patient age 18 or older
* Transfemoral transcatheter aortic valve replacement (TAVR)
* Implantation of CoreValve replacement valve
* Access using 14 or 16 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.
* 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.

Primary outcomes:
measure: Number of Patients With Vascular Complications
timeFrame: Day 5 post-procedure
measure: Number of Patients With Life-threatening bleeding
timeFrame: Hour 24 post-procedure
measure: Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition
timeFrame: Hour 24 post-procedure
measure: Time to Hemostasis
timeFrame: 1 hour post procedure
Secondary outcomes:
measure: Additional Closure Device Use
timeFrame: Hour 24 post-procedure
measure: In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions
timeFrame: Day 5 post-procedure
measure: Number of Patients With Limb Ischemia Related to TAVR During Index Admission
timeFrame: Day 5 post-procedure
measure: Limb Ischemia Related to TAVR
timeFrame: Day 30 post-procedure
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suhail Q Allaqaband, MD
role: PRINCIPAL_INVESTIGATOR
References: