JenaValve’s Trilogy THV Evaluated in Expanded Cohort of ALIGN-AR Pivotal Trial

April 7, 2025—JenaValve Technology, Inc. recently announced results from the expanded cohort of 500 patients in the ALIGN-AR pivotal trial. ALIGN-AR is evaluating the company’s Trilogy transcatheter heart valve (THV) system in high-risk patients with symptomatic, severe aortic regurgitation (AR).

According to the company, the late-breaking clinical trial results underscore the safety and efficacy of the Trilogy THV system in high surgical-risk patients with severe, symptomatic AR. The analysis includes procedural and 30-day safety outcomes from the continued-access protocol of ALIGN-AR along with the 1-year follow-up data on more than 300 patients, including 180 from the core ALIGN-AR trial.

The findings were presented at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago, Illinois.

As summarized in JenaValve’s press release, the expanded cohort’s composite 30-day primary safety endpoint was 26.2% with an upper one-sided 97.5% confidence interval of 30.1%, significantly below the prespecified noninferiority margin of 40.5%. Additionally, 1-year mortality was 8.1%, well below the study’s predefined performance goal of 25%, noted the company.

“The robust results from this large, 500-patient cohort provide compelling evidence for the clinical value of the Trilogy valve,” commented Raj Makkar, MD, in the company’s press release. “We now have a device success rate of > 95% across 500 patients compared to the success rates of 80 to 85% with available transcatheter aortic valve replacement (TAVR) valves when used in AR patients. This represents a significant advancement in TAVR technology that may fundamentally improve treatment pathways for this patient population.”

Dr. Makkar, the study’s highest-enrolling investigator, is Vice President of Cardiovascular Innovation and Intervention at Cedars-Sinai and an interventional cardiologist in the Smidt Heart Institute in Los Angeles, California.

The Trilogy THV is an investigational device, limited by United States law to investigational use, advised the company.