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COMPLETED
NCT06983938
NA

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

Sponsor: Baylor Research Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2025-02-12

Completion Date

2025-10-15

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States