JenaValve’s ALIGN-AR Pivotal Trial Results for Trilogy THV System Are Published

March 28, 2024—JenaValve Technology, Inc. announced the publication of results from the ALIGN-AR pivotal trial, which is a prospective, multicenter study evaluating the use of the company’s Trilogy transcatheter heart valve (THV) system in high-risk patients with symptomatic moderate-to-severe or severe aortic regurgitation (AR). ALIGN-AR met prespecified noninferiority criteria for its primary safety endpoint and primary efficacy endpoint.

The study by Torsten P. Vahl, MD, et al is available online ahead of print in The Lancet.

Dr. Vahl, who is from Columbia University Irving Medical Center in New York, New York, is a principal investigator of ALIGN-AR. Vinod H. Thourani, MD, the Bernie Marcus Chairman of the Department of Cardiovascular Surgery at Piedmont Heart Institute in Atlanta, Georgia, is also a principal investigator of the ALIGN-AR trial. In October 2023, the company announced that Dr. Thourani presented the findings during a late-breaking clinical trial session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held in San Francisco, California.

According to the company, the ALIGN-AR investigators concluded that the Trilogy THV system showed a high technical success rate and promising safety profile, as well as low morbidity and mortality at 1-year follow-up. Investigators noted 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.

“The ALIGN-AR study demonstrated both safety and effectiveness of treating native AR with JenaValve’s Trilogy THV system, a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe AR who are at high risk for mortality or complications after surgical aortic valve replacement,” commented Dr. Thourani is the company’s press release. “The observed short-term clinical and hemodynamic outcomes are very promising, as are signs of left ventricular remodeling. We hope to have the opportunity to use this valve, pending regulatory approval, for patients who are indicated and have limited surgical options.”

Dr. Vahl stated, “We are incredibly pleased to see the formal publication of ALIGN-AR results in The Lancet. In addition to meeting its primary safety and efficacy endpoints, the THV system demonstrated exceptional technical performance and reversal of cardiac damage caused by AR. We would like to thank the ALIGN-AR investigators and site participants for their tremendous work and impact on patients during the course of this trial, and in the many discussions it has inspired since.”

Raj Makkar, MD, from Cedars-Sinai Medical Center in Los Angeles, California, was the highest enroller in the ALIGN-AR trial.

“The Trilogy system fills an unmet need for our patients with symptomatic AR,” commented Dr. Makkar in the press release. “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.”

Dr. Makkar added, “If approved, I believe that there are more patients that could benefit from this therapy than we ever thought before.”

JenaValve stated that the ALIGN-AR trial is a landmark prospective, single-arm investigation device exemption study designed to assess the safety and efficacy of the Trilogy THV system for transcatheter aortic valve replacement procedures in high-risk patients with symptomatic, severe AR. Results from the study are intended to support a premarket approval submission to the FDA. The Trilogy THV system has received CE Mark approval and is available in Europe.