JenaValve Initiates Trilogy Trial to Compare TAVR with Surgical Aortic Valve Replacement

Key Insights

• JenaValve has received approval to commence the ARTIST trial, a randomized controlled study evaluating its Trilogy transcatheter heart valve (THV) system.
• The ARTIST trial will compare the Trilogy valve against surgical aortic valve replacement (SAVR) in non-high-risk patients with moderate-to-severe and severe aortic regurgitation (AR).
• Two-year follow-up data from the ALIGN-AR trial demonstrated the sustained safety and efficacy of the Trilogy THV system in high-risk patients with severe, symptomatic AR.

JenaValve has announced the initiation of the ARTIST trial, a randomized controlled study designed to compare its Trilogy transcatheter heart valve (THV) system with surgical aortic valve replacement (SAVR) in patients with aortic regurgitation (AR). The trial, slated to begin early next year, aims to provide clinicians with critical data on the efficacy and safety of TAVR compared to traditional surgery.

The ARTIST trial will focus on non-high-risk patients with moderate-to-severe and severe AR. This study is a significant step in expanding the treatment options for patients with AR, a condition where the aortic valve does not close properly, leading to blood leaking back into the left ventricle.

ALIGN-AR Trial Follow-Up Data

In addition to the ARTIST trial, JenaValve presented two-year follow-up data from its ALIGN-AR trial at TCT 2024. The ALIGN-AR trial evaluated the Trilogy THV system in high-risk patients with severe, symptomatic AR. The follow-up data confirmed the continued safety and efficacy of the Trilogy valve, with the all-cause mortality rate remaining below the study’s predefined performance goal of 25% at one year. The two-year data also highlighted excellent hemodynamic outcomes, low rates of paravalvular leak, and sustained improvements in the patients' quality of life.

Strategic Context

Edwards Lifesciences is in the process of acquiring JenaValve as part of a $1.2 billion double M&A transaction. Edwards anticipates that the Trilogy valve will receive FDA approval for treating AR in late 2025. The ARTIST trial is expected to play a crucial role in supporting this regulatory approval and expanding the clinical applications of the Trilogy system.

Expert Commentary

“Our ARTIST RCT reflects our unwavering commitment to advancing research that enhances patient outcomes and offers effective treatment alternatives,” said Dr. Duane Pinto, chief medical officer at JenaValve. “With the commitment of our dedicated investigators, we anticipate a swift enrollment process that brings us closer to transforming existing treatment.”