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

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Los Angeles

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing two devices to see which one stops bleeding better after a heart valve procedure. It focuses on patients having this specific surgery and aims to find a quicker, safer way to seal the artery.

Research Team

Eligibility Criteria

Inclusion Criteria

A large catheter (14-16 French) will be used to replace the aortic valve.

Exclusion Criteria

Use of an anticoagulant other than unfractionated heparin or bivalirudin during the procedure.

Inability of the patient to personally consent for the study. (no surrogate consent)

The medical procedure will not use sheathless guides.

Treatment Details

Interventions

• Perclose (Vascular Closure Device)
• Statseal (Hemostatic Agent)

Participant Groups

Group I: Perclose with Statseal Device Experimental Treatment 2 Interventions

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.

Group II: Perclose Only Active Control 1 Intervention

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.

Perclose is already approved in Canada for the following indications:

Approved in Canada as Perclose ProGlide for:

• Closure of femoral arterial puncture sites following diagnostic and interventional procedures

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California Ronald Reagen Medical Center Los Angeles, CA

University of California Ronald Reagan Medical Center Los Angeles, CA

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1594

Patients Recruited

10,430,000+