JenaValve Presents 2-Year ALIGN-AR Data for Trilogy THV

November 12, 2024—JenaValve Technology, Inc., announced 2-year follow up data from the ALIGN-AR pivotal trial of the company’s Trilogy transcatheter heart valve (THV) system. The company also announced the approval and initiation of the ARTIST randomized controlled trial (RCT).

According to the company, the ALIGN-AR data confirmed the continued safety and efficacy of the Trilogy heart valve system for patients with severe, symptomatic aortic regurgitation (AR) at high risk for surgery.

At 2 years, the all-cause mortality rate remained below the study’s predefined performance goal of 25% at 1 year. The 2-year data also demonstrated excellent hemodynamic outcomes, very low rates of paravalvular leak, and sustained improvements in quality of life, advised JenaValve.

ALIGN-AR Principal Investigator Torsten Vahl, MD, presented the study results at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

“We are incredibly pleased that the ALIGN-AR 2-year follow-up results reinforce the safety and efficacy endpoints of the THV system, highlighting its exceptional performance and ability to reverse cardiac damage caused by AR,” commented Dr. Vahl in JenaValve’s press release. Dr. Vahl is from Columbia University Irving Medical Center in New York, New York.

JenaValve stated that the ARTIST trial aims to provide critical information to clinicians on transcatheter aortic valve replacement with the Trilogy valve as an option for patients with AR in comparison to surgery.

The prospective, randomized trial will compare outcomes between non–high-risk patients with moderate-to-severe and severe AR treated with the Trilogy device versus those patients undergoing surgical aortic valve replacement. The ARTIST study is expected to begin enrolling participants early in 2025, noted JenaValve.

Vinod H. Thourani, MD, who is Chairman of Cardiovascular Surgery at Piedmont Heart Institute in Atlanta, Georgia, is Principal Investigator of the ARTIST RCT.

“AR is a deadly disease that is overlooked and undertreated” commented Dr. Thourani in JenaValve’s press release. “The rigorous trial design comparing to surgery sets the stage for impactful future treatment decisions. Thank you to the clinical staff and everyone involved in initiating this important trial.”

JenaValve advised that the Trilogy THV system received CE Mark approval. In the United States, the Trilogy device is limited by law to investigation use only.