Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Hematoma; Arterial Occlusion

• Registration Number: NCT05637970
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that manual pressure will be held, shorter procedure time and less complications after the procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-06
• Study Start: 2023-01-12
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Results First Submitted: 2024-08-02
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Results First Posted: 2025-02-19
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Delivery of a 14-16 French Transcatheter aortic valve replacement system

Exclusion Criteria

• Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
• Use of an anticoagulant other than unfractionated heparin or bivalirudin during the procedure.
• Any use of glycoprotein inhibitors or cangrelor.
• Use of sheathless guides.
• Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
• Any active treatment with oral anticoagulants continued during course of procedure.
• Presence of arteriovenous dialysis fistula in the ipsilateral leg.
• Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band.
• Inability of the patient to personally consent for the study. (no surrogate consent)
• Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Hemostasis	24 hours post procedure (± 1 hour)	From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.

Secondary Outcome Measures

Name	Time	Method
Patients With Hematoma	24 hours post procedure (± 1 hour)	Presence of small \<5cm, medium 5-10cm, or large \>10cm hematoma based on physical exam or diagnostic imaging.

Trial Locations

Locations (1)

University of California Ronald Reagan Medical Center; 🇺🇸 Los Angeles, California, United States