Home › Aortic Valve Stenosis › NCT07205068

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

Who can join

Ages 18 and older · All sexes

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

About the study

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)

What is being tested

• Shockwave M5 IVL Catheter (device)
• Modified Seldinger Technique (procedure)
• Modified Seldinger Technique (procedure)

Sponsor: University of Tennessee Graduate School of Medicine · Participants: 100 · Started: Oct 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07205068

Locations in the U.S.

Conditions

• Aortic Valve Stenosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.