CompletedNot Applicable

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

United States92 participantsStarted 2025-02-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 Exclusion Criteria: * 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.

What they're measuring

Number of Participants With Main Access-related Bleeding and Vascular Complications

Timeframe: Periprocedural through hospital discharge, an average of 1.5 days

Trial details

NCT IDNCT06983938

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-13

Results submitted2026-01-13

View on ClinicalTrials.gov More Transcatheter Aortic Valve Replacement trials