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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05637970
• Other study ID #: 22-000961
• Status: Completed
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: July 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusion
• Arterial Occlusive Diseases
• Cardiovascular Diseases
• Hematoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California Ronald Reagan Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hemostasis	From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.	24 hours post procedure (± 1 hour)
Secondary	Percent of patients with hematoma	Presence of small <5cm, medium 5-10cm, or large >10cm hematoma based on physical exam or diagnostic imaging.	24 hours post procedure (± 1 hour)