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

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ClinicalTrials.gov Identifier: NCT05637970
Recruitment Status : Recruiting
First Posted : December 6, 2022
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
David Tehrani, MD, MS, University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arterial Occlusion Cardiovascular Diseases Hematoma Device: Perclose Device: Statseal Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study Comparing the Time to Ambulation and Safety of Using a Closure Device Alone and in Conjunction With a Potassium Ferrate Pad (Statseal) Following Transcatheter Aortic Valve Replacement Via the Femoral Artery
Actual Study Start Date : January 12, 2023
Estimated Primary Completion Date : December 7, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Perclose Only
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
 Device: Perclose
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Other Name: Suture based hemostasis device
Experimental: Perclose with Statseal Device
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
 Device: Perclose
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Other Name: Suture based hemostasis device

Device: Statseal
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manualpressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Other Name: potassium ferrate disc with topical hydrophilic polymer


Outcome Measures
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Primary Outcome Measures :
  1. Time to hemostasis [ Time Frame: 24 hours post procedure (± 1 hour) ]
    From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.


Secondary Outcome Measures :
  1. Percent of patients with hematoma [ Time Frame: 24 hours post procedure (± 1 hour) ]
    Presence of small <5cm, medium 5-10cm, or large >10cm hematoma based on physical exam or diagnostic imaging.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637970


Contacts
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Contact: David M Tehrani, MD MS 310-206-6286 dtehrani@mednet.ucla.edu

Locations
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United States, California
University of California Ronald Reagen Medical Center Recruiting
Los Angeles, California, United States, 90025
Contact: David M Tehrani, MD MS    858-336-0666    david.m.tehrani@gmail.com   
Sponsors and Collaborators
University of California, Los Angeles
More Information
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Responsible Party: David Tehrani, MD, MS, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05637970    
Other Study ID Numbers: 22-000961
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cardiovascular Diseases
Hematoma
Hemorrhage
 Pathologic Processes
Hemostatics
Coagulants