JenaValve Publishes ALIGN-AR Pivotal Trial Results

JenaValve, maker of the Trilogy transcatheter heart valve (THV) system, has published results from its ALIGN-AR pivotal trial in The Lancet.
 
The prospective, multicenter study is evaluating Trilogy’s use in high-risk patients with symptomatic, moderate-to-severe or severe aortic regurgitation.
 
The ALIGN-AR trial met non-inferiority criteria for its primary safety and efficacy endpoints—investigators concluded Trilogy has a high technical success rate and promising safety profile. It also has a low morbidity and mortality rate at one-year of follow-up.
 
Further, investigators remarked that Trilogy “provided favorable hemodynamics, with low mean gradients and paravalvular leak rates and significant clinical improvement,” and found “substantial improvements in patient-reported outcomes and left-ventricular remodeling” with its use.
 
Results from the study are intended to support premarket approval submission to the U.S. Food and Drug Administration (FDA). If approved, Trilogy THV will become the first, only transcatheter aortic valve replacement (TAVR) system in the U.S. indicated to treat symptomatic, severe aortic regurgitation, according to JenaValve.
 
“The Trilogy System fills an unmet need for our patients with symptomatic aortic regurgitation. Initially, we didn’t know how many patients there would be, as TAVR was never truly an option for these patients, but as the trial progressed and awareness improved, I saw firsthand a substantial increase in the number of patients with AR,” said Raj Makkar, MD, Cedars Sinai, the highest enroller in the ALIGN-AR trial. “If approved, I believe that there are more patients that could benefit from this therapy than we ever thought before.”
 
“I am proud of the patients, investigators, JenaValve staff, and countless others who helped achieve this extraordinary milestone in expanding transcatheter therapies for patients with aortic regurgitation. The positive outcomes reported from the ALIGN-AR trial in The Lancet usher in a new era for these patients,” added Duane Pinto, MD, MPH, chief medical officer at JenaValve.