Open Actively Recruiting

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

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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.

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Study Stats
Protocol No.
22-000961
Category
Cardiology
Principal Investigator
DAVID TEHRANI
Contact
Olcay Aksoy
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05637970
For detailed technical eligibility, visit ClinicalTrials.gov.