Using Intravascular Lithotripsy for High-Risk Patients Needing Heart Valve Replacement

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

This study is testing whether a new procedure called Intravascular Lithotripsy can safely help high-risk patients with severe artery disease get a heart valve replacement through a less invasive method.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Baylor Research Institute (Academic / other)
• Locations: 1 site (Plano, Texas)
• Trial ID: NCT05862558 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety and efficacy of Intravascular Lithotripsy (IVL) in patients with severe iliac disease who are undergoing transfemoral Transcatheter Aortic Valve Replacement (TAVR) due to symptomatic aortic stenosis. The study will involve patients who are typically considered for alternative access routes due to prohibitive iliofemoral disease. Data will be collected prospectively and analyzed to determine the effectiveness of IVL in facilitating TAVR procedures. The study is conducted at Baylor Scott and White Heart Hospital in Plano, Texas.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with severe symptomatic aortic stenosis and significant iliofemoral disease that prevents traditional TAVR access.

Not a fit: Patients who are not eligible for TAVR or have contraindications to Intravascular Lithotripsy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enable high-risk patients with severe iliac disease to safely undergo TAVR, improving their treatment options.

How similar studies have performed: While this approach is innovative, similar studies using IVL in vascular interventions have shown promising results, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent
2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
5. Subjects can provide written, informed consent.

Exclusion Criteria:

1. Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.
2. Subject who has contraindications to IVL
3. Subject who has contraindications or is not eligible for TAVR

Where this trial is running

Plano, Texas

• Baylor Scott and White Heart Hospital — Plano, Texas, United States (Recruiting)

Conditions Iliac Disease; Aortic Valve Stenosis