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

Description

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.

Conditions

Transcatheter Aortic Valve Replacement, Closure Technique

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Transcatheter Aortic Valve Replacement
Intervention / Treatment

-

Contacts and Locations

Plano

Baylor Scott & White The Heart Hospital - Plano, Plano, Texas, United States, 75093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years old
  • * Planned to undergo transcatheter aortic valve replacement via femoral access
  • * Able to provide written informed consent prior to study participation
  • * Non-femoral access
  • * Previous repair or intervention of the common femoral artery
  • * Previous pseudoaneurysm of the common femoral artery
  • * Children below 18 years, prisoners, and patients who are unable to provide consent are excluded.
  • * In another research study that has not granted permission to dual-enroll.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor Research Institute,

Study Record Dates

2026-12-01