Shockwave Treatment for Aortic Stenosis

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

Recruiting N/A Interventional Study
Aortic Stenosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
University of Tennessee Graduate School of Medicine · Other
Who this trial is looking for

This trial is looking for patients who have severe aortic stenosis and are planning to undergo a specific procedure called TAVR. Participants will be monitored for any complications at the access site of the treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am over 18 years old.
  • I have been diagnosed with severe aortic stenosis.
  • I can read and understand the study procedures.
  • I am willing to participate and sign a consent form.
  • I have more than a 90-degree arc of calcium at the access site.

You may not be able to join if

  • I cannot understand the study procedures.
  • I am unwilling to give consent.
  • I have cognitive impairments that affect my ability to give consent.
  • I have an unfavorable calcium distribution in my femoral artery.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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)

Trial Locations
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Eligibility Criteria
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 pe…
Contacts

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