Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR

Conditions

• Transcatheter Aortic Valve Replacement

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Single Perclose Pro vascular closure device — DEVICE
  Use of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath.
• Dual Perclose vascular closure device — DEVICE
  Use of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath.

Study Details

This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure 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.

Key Dates

Start date

Jun 16, 2025

Status verified

Jan 2026

Primary completion

Jun 30, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Single Device
  A single Perclose device will be used for pre-closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis.
• Active Comparator: Two device
  Two Perclose devices will be used for pre-closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis.

Primary Outcome Measure

Number of Patients With Vascular Complications [ Time Frame: Day 5 post-procedure ]

Central Contacts

• Suhail Q Allaqaband, MD
  414-649-3491
  [email protected]

Locations (1)

Find similar trials in Milwaukee, WI

Related Studies

• CT TAVR Abdomen Study
  PHASE4 · Recruiting · University of Maryland, Baltimore · Baltimore, Maryland