NCT06983938

This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement

Randomized Trial Comparing Dual Perclose Vs Single Angioseal And Perclose in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.

Detailed description

This is a prospective, randomized, parallel, open-label, single-center, non-inferiority study. Approximately 90 patients undergoing Transcatheter Aortic Valve Replacement with femoral access will be randomized in a 1:1 fashion to receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal for closure. The primary end point of this study is the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication. Secondary end points include periprocedural complications (such as acute vessel closure, leg embolization and perforation), procedural characteristics (total duration, fluoroscopy time, contrast volume, length of hospital stay), and cost of hospitalization. A routine follow-up visit assessment will be performed at 30 days in the valve clinic and the assessment will include: any clinical change, re-interventions, and peripheral pulse evaluation.

Conditions

• Transcatheter Aortic Valve Replacement
• Closure Technique

Interventions

Type	Name	Description
DEVICE	Double Perclose Proglide	Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
DEVICE	Single Perclose Proglide plus Angioseal	Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.

Timeline

• Start date: 2025-02-12
• Primary completion: 2025-08-13
• Completion: 2025-10-15
• First posted: 2025-05-21
• Last updated: 2026-03-16
• Results posted: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study