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NCT06871774 | NOT YET RECRUITING | Transcatheter Aortic Valve Replacement

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

Wake Forest University Health Sciences

Brief Summary:

This study will compare the use of one Perclose device to the usual approach of two devices 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.

Condition or disease

Transcatheter Aortic Valve Replacement

Intervention/treatment

Single Perclose Pro vascular closure device

Dual Perclose vascular closure device

Phase

NA

Detailed Description:

This single-center randomized trial compares single versus dual Perclose devices for initial closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two closure approaches. The study will provide valuable insights into optimizing 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 closure strategy arm.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
  • * Valve-in-Valve Procedures: Patients undergoing valve-in-valve procedures.
  • * 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.
  • * Obesity or Underweight: Class III Obesity (body mass index \> 40 kg/m²) or underweight (body mass index \< 20 kg/m²).
  • * Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
  • * Contraindications: Patients with contraindications for the use of Perclose device.
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR

Location Details

NCT06871774

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How to Participate

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Locations

Not yet recruiting

United States, Wisconsin

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States, 53215