This study is looking at how well and safely a device called the Shockwave Balloon works for people who need a heart valve replacement (TAVR) but also have severe hardening of the arteries in their pelvis (iliac disease). Normally, this iliac disease would make it hard to do TAVR through the leg, requiring a different approach. The Shockwave Balloon uses sound waves to break up calcium in these arteries. The study wants to see if using this device helps people successfully receive TAVR through the leg. You might be able to join if you are between 18 and 90 years old, have severe iliac disease and severe aortic stenosis, and are planning to have a TAVR procedure.

Study design

This is an observational study involving about 50 participants. It's a single-arm study, meaning everyone receives the same intervention.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The study measures success at the time of the Shockwave procedure and again within 30 days of the TAVR procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.