A recent study presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) demonstrated promising results for the Trilogy transcatheter aortic valve replacement (TAVR) system, specifically designed for patients with aortic regurgitation. The study, which involved 500 patients, found an overall mortality rate of just 8.1% at one year—far below the trial’s prespecified goal of 25%—indicating the device’s safety and efficacy in treating this condition.
Aortic regurgitation occurs when the aortic valve doesn’t close tightly, causing blood to leak backward and reducing the blood flow to the body. The Trilogy system, developed by JenaValve, is the first device tailored for replacing the aortic valve in these patients, using anchors to attach to the three leaflets of the aortic valve.
The ALIGN-AR trial enrolled patients between 2018 and 2024, with a cohort of 180 patients in a premarket approval group and 320 patients in a continued access cohort. All patients had moderate to severe symptomatic aortic regurgitation and underwent TAVR using the Trilogy valve. With approximately 360 patients having at least one year of follow-up and 200 patients with two years of follow-up, the trial’s primary endpoint was a one-year mortality rate. The survival rate at one year was 91.9%, exceeding the trial’s prespecified threshold of 75%, thereby meeting the non-inferiority criteria.
The study also reported a high device success rate of 96.4%, with only 1.5% of patients experiencing more than mild regurgitation at 30 days. Additionally, the 30-day mortality rates were lower in the continued access cohort (0.9%) compared to the premarket cohort (2.2%), suggesting improvements in patient selection and procedural technique over time.
Raj Makkar, MD, vice president of Cardiovascular Innovation and Intervention at Cedars-Sinai in Los Angeles and the study’s first author, highlighted the significant improvement in patients’ quality of life post-procedure. “Not only did we meet our prespecified safety and efficacy endpoint, we also saw excellent valve hemodynamics and valve function, and there was a very low rate of leakage across and around the valve,” Makkar said.
Furthermore, the study revealed evidence of left ventricular reverse remodeling, with reduced ventricular volumes, improved ejection fraction, and decreased left ventricular mass—all of which are indicators of better long-term outcomes. The findings are particularly important as aortic regurgitation, like aortic stenosis, can lead to heart failure if untreated. The Trilogy valve’s success represents a significant advancement in treating this condition, offering a less invasive option compared to open-heart surgery.
However, nearly one-quarter of patients required a pacemaker after the procedure. Researchers are now exploring ways to reduce this need through modifications to the procedure or device. Additionally, a randomized controlled trial comparing the Trilogy valve to open-heart surgery is planned to further assess its benefits.