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

Not Applicable

Not yet recruiting

• Conditions: Transcatheter Aortic Valve Replacement

• Registration Number: NCT06871774
• Lead 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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-12
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Patients With Vascular Complications	Day 5 post-procedure	Number of subjects in each group experiencing major or minor vascular complications directly related to the TAVR procedure occurring during the index hospitalization.
Number of Patients With Life-threatening bleeding	Hour 24 post-procedure	Number of subjects in each group experiencing any bleeding event related to the TAVR procedure that is life-threatening within 24 hours post-procedure.
Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition	Hour 24 post-procedure	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.
Time to Hemostasis	1 hour post procedure	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.

Secondary Outcome Measures

Name	Time	Method
Additional Closure Device Use	Hour 24 post-procedure	Number of subjects requiring use of additional closure devices beyond the initial closure strategy required to achieve hemostasis at the femoral access site within 24 hours post-procedure. The number and type of devices will be recorded for each subject.
In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions	Day 5 post-procedure	Number of subjects in each group experiencing severe vascular complications that necessitate either percutaneous procedures or surgical interventions during the index hospitalization.
Number of Patients With Limb Ischemia Related to TAVR During Index Admission	Day 5 post-procedure	Number of subjects in each group experiencing significant peripheral ischemia related to the arteriotomy closure between the TAVR procedure and discharge.
Limb Ischemia Related to TAVR	Day 30 post-procedure	Number of subjects in each group experiencing significant peripheral ischemia related to the arteriotomy closure monitored within 30 days post procedure.

Trial Locations

Locations (1)

Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States