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

N/A

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post procedure (± 1 hour)

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Hematoma and Bleeding
Cardiovascular Disease
Arterial Blockage
Hematoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post procedure (± 1 hour)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post procedure (± 1 hour)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post procedure (± 1 hour) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to hemostasis

Secondary study objectives

Percent of patients with hematoma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Perclose with Statseal DeviceExperimental Treatment2 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 OnlyActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perclose

2023

N/A

~50

Statseal

2023

N/A

~50