Recruiting

TAVR

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT07205068

Conditions

Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Shockwave M5 IVL Catheter

Modified Seldinger Technique

Modified Seldinger Technique

Study Details

Brief 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)

Conditions

Aortic Stenosis

Study ID

NCT07205068

Start date

Oct 4, 2025

Status verified date

Aug, 2026

Completion date

Oct 4, 2028

Anticipated

Primary completion date

Oct 4, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Shockwave model (M5) Intravascular Lithotripsy (IVL)

Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique

active comparator: Standard femoral access

Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries

Interventions

Shockwave M5 IVL Catheter

The Shockwave M5 IVL Catheter is a balloon catheter designed to modify calcified arterial plaque using intravascular lithotripsy prior to vascular access

Modified Seldinger Technique

Standard of care for femoral access in patients with calcified femoral arteries

Modified Seldinger Technique

Standard femoral artery access using the modified Seldinger technique without any prior vessel preparation or plaque modification.

Primary outcome measure

  • Evaluate for contrast extravasation post closure of femoral artery at the end of the procedure [ Time Frame: Immediately post-procedure ]

Central Contacts and Locations

Locations

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Savannah Allen, MPH Study Coordinator

+1865-305-9522skallen1@utmck.edu

Principal Investigator:

Raj Baljepally, MD

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Aortic Stenosis
  • Transcatheter aortic valve replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2026-08-17.