Perclose Devices for TAVR

Recruiting in Palo Alto (17 mi)

Overseen bySuhail Q Allaqaband, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will compare the use of one Perclose device to the usual approach of two devices during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.

Eligibility Criteria

This trial is for patients undergoing a heart valve replacement procedure called TAVR. Participants should be suitable candidates for the procedure and specifically require large-bore access closure, which is part of the process.

Inclusion Criteria

* Patient age 18 or older

* Transfemoral transcatheter aortic valve replacement (TAVR)

* Implantation of CoreValve replacement valve

See 2 more

Treatment Details

Interventions

Dual Perclose vascular closure device (Vascular Closure Device)
Single Perclose Pro vascular closure device (Vascular Closure Device)

Trial OverviewThe study tests if using one Perclose Pro vascular closure device is as effective as using two such devices in stopping bleeding after TAVR. It compares time to hemostasis (bleeding stop) and rates of complications between the single-device and dual-device methods.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Single DeviceExperimental Treatment1 Intervention

A single Perclose device will be used for initial closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis.

Group II: Two deviceActive Control1 Intervention

Two Perclose devices will be used for initial closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis.