NCT06871774

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

Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-closure strategy arm.

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

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

Timeline

• Start date: 2025-06-16
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-03-12
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study