JenaValve’s Trilogy THV System Assessed in ALIGN-AR Pivotal Trial

October 24, 2023—JenaValve Technology, Inc. announced results from the ALIGN-AR pivotal trial of the company’s Trilogy transcatheter heart valve (THV) system in high-risk patients with symptomatic, severe aortic regurgitation (AR).

The ALIGN-AR trial is a prospective, single-arm investigation device exemption study designed to assess the safety and efficacy of the Trilogy THV system in high-risk patients with symptomatic, severe AR. Results from the study are intended to support a premarket approval submission to the FDA for the device for transcatheter aortic valve replacement (TAVR) in these patients with symptomatic, severe AR.

Vinod Thourani, MD, from the Piedmont Heart Institute in Atlanta, Georgia, presented the ALIGN-AR data during a late-breaking clinical trial session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

According to JenaValve, the trial met prespecified noninferiority criteria for its primary safety endpoint and primary efficacy endpoint.

The ALIGN-AR investigators concluded that the Trilogy THV’s performance was excellent with large effective orifice area and low transvalvular gradients, as well as low paravalvular regurgitation (0% ≥ moderate at 1 year). In addition, echocardiography demonstrated significant improvement in left ventricular (LV) remodeling, and patients reported sustained improvement in quality of life and heart failure functional status through 1 year.

Torsten P. Vahl, MD, serves as principal investigator of the ALIGN-AR trial.

“We are encouraged to see the significant LV mass reduction at over 20% and substantial improvement in quality of life in the ALIGN-AR pivotal trial results,” commented Dr. Vahl in JenaValve’s press release. “Pending United States regulatory approval, we look forward to being able to offer the Trilogy THV System to our patients with symptomatic, severe AR.”

Raj Makkar, MD, from Cedars-Sinai Medical Center in Los Angeles, California, added, “In addition to its safety profile, the Trilogy THV system offered exceptional hemodynamic and technical performance in the ALIGN-AR trial. I am excited that patients with symptomatic, severe AR may have the option to receive TAVR and its benefits in the future.”

The Trilogy THV System received CE Mark approval and is available in Europe. In the United States, it is an investigational device limited by federal law to investigational use, advised JenaValve.