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

Completed · Not applicable

Conditions studied: Transcatheter Aortic Valve Replacement, Closure Technique

In brief

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.

Key facts

Study ID

NCT06983938

Run by

Baylor Research Institute

People needed

92

Starts

2025-02-12

Expected to finish

2025-10-15

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old
• Planned to undergo transcatheter aortic valve replacement via femoral access
• Able to provide written informed consent prior to study participation

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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