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Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure

RECRUITINGN/ASponsored by University of Tennessee Graduate School of Medicine
Actively Recruiting
PhaseN/A
SponsorUniversity of Tennessee Graduate School of Medicine
Started2025-10-04
Est. completion2026-11-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07205068

Summary

The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. \>18 years of age
2. Patient with a diagnosis of severe aortic stenosis undergoing TAVR
3. Participants must be able to read and understand study procedures
4. Willing to participate and sign an ICF
5. Patients with \> 90-degree arc of calcium at the large bore access site per CT documentation

Exclusion Criteria:

1. Unable to understand study procedures
2. Unwilling to give consent
3. Patients with cognitive impairments that can affect their ability to give consent
4. Unfavorable calcium distribution of femoral artery

Conditions2

Aortic StenosisHeart Disease

Locations1 site

University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Savannah Allen, MPH Study Coordinator+1865-305-9522skallen1@utmck.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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