Raj Makkar explains late-breaking ALIGN-AR TAVR trial for aortic stenosis

Highly encouraging results were seen in the first 500 pure aortic regurgitation (AR) patients treated in the Align-AR trial using the JenaValve transcatheter aortic valve replacement (TAVR) system, presented as a late-breaking study at the American College of Cardiology (ACC) 2025 annual meeting.

This late-breaking clinical trial marks a significant step forward for a population long underserved by current transcatheter options. Unlike aortic stenosis, pure AR presents unique challenges due to the absence of valve calcification, making standard TAVR devices more likely to embolize. The JenaValve, was designed specifically for non-calcified anatomy and has received FDA Breakthrough Device designation.

"The prognosis in patients who have symptomatic aortic regurgitation, especially when they have  NYHA Class III or IV heart failure symptoms is pretty dismal. Almost half the patients may be dead at the end of five years. The only approved treatment is surgery, but a lot of patients are not treated because they're high-risk surgical candidates, explained Raj Makkar, MD, director, interventional cardiology, director, Interventional Cardiology Research Program and professor of medicine, Smidt Heart Institute, Cedars-Sinai Hospital, who presented the data at ACC and spoke to cardiovascular Business in a video interview.