Status:
COMPLETED
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
Lead Sponsor:
Baylor Research Institute
Conditions:
Transcatheter Aortic Valve Replacement
Closure Technique
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 comm...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06983938
Start Date
February 12 2025
End Date
October 15 2025
Last Update
November 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093