JenaValve has announced the commencement of the JENA-VAD registry, a prospective, multi-center, single-arm clinical study designed to evaluate the Trilogy transcatheter heart valve (THV) system's performance in treating severe symptomatic aortic regurgitation (AR) in patients supported by a continuous flow left ventricular assist device (cfLVAD). The first patient procedure was successfully completed at Cedars-Sinai Medical Center in Los Angeles.
Addressing Aortic Regurgitation in LVAD Patients
The JENA-VAD registry, nested within the broader ALIGN-AR study, seeks to address a critical gap in treatment options for the significant proportion of LVAD patients who develop AR. According to JenaValve, approximately one-third of LVAD patients experience significant AR, leading to an increased risk of heart failure. Current treatment options for these patients are limited, highlighting the urgent need for innovative solutions.
First Case and Investigator Insights
Dr. Raj Makkar of Cedars-Sinai Medical Center, who performed the first procedure and serves as a registry investigator, emphasized the potential of the registry to inform treatment strategies for this challenging patient population. "The registry can help explore treatments for the large population of LVAD patients suffering from AR," said Dr. Makkar. He added that the ALIGN-AR study provides a rationale for further investigating TAVR with a dedicated device as a potential solution for patients with significant AR.
Trilogy THV: A Potential Solution
The Trilogy THV system is designed to treat symptomatic AR. It is currently available commercially in Europe under CE mark, and JenaValve anticipates FDA approval in the United States in late 2025. The JENA-VAD registry will contribute to the growing body of evidence supporting the use of Trilogy in this specific patient population.
Company Perspective
John Kilcoyne, CEO of JenaValve, stated, "Our mission is to address the critical gap for the one-third of patients with left ventricular assist devices (LVADs) that develop significant aortic regurgitation (AR) and face significant risk of heart failure. These patients have very limited treatment options, so with the Trilogy system, we seek to understand whether there can be a new pathway forward."
Acquisition by Edwards Lifesciences
JenaValve is in the process of being acquired by Edwards Lifesciences as part of a $1.2 billion double M&A transaction, which also includes Endotronix. This acquisition underscores the growing interest in innovative solutions for structural heart disease.
