JENA-VAD Registry for JenaValve’s Trilogy THV System Enrolls First Patient

December 16, 2024—JenaValve Technology, Inc., developer of the Trilogy transcatheter heart valve (THV) system announced the completion of the first patient procedure for inclusion in the JENA-VAD registry. The transcatheter aortic valve replacement (TAVR) procedure was conducted by registry investigator Raj Makkar, MD, at Cedars-Sinai Medical Center in Los Angeles, California.

According to the company, JENA-VAD is a prospective, multicenter, single-arm clinical registry nested within the ALIGN-AR pivotal trial, which is evaluating the safety and efficacy of the Trilogy system in the treatment of severe symptomatic aortic regurgitation (AR) in patients with a continuous-flow left ventricular assist device (LVAD).

“We are excited for the initiation of the JENA-VAD registry and this meaningful step in exploring treatments for the large population of LVAD patients suffering from AR,” commented Dr. Makkar in the JenaValve’s press release. “The positive results of the ALIGN-AR study provide a strong base and justification for moving forward with this registry studying whether TAVR with a dedicated device may be a solution for these patients with significant AR. We look forward to the results of this registry.”

Nir Uriel, MD, who serves as chair and national Principal Investigator of the JENA-VAD registry, added, “As a heart failure cardiologist, I focus on very sick patients including heart transplant patients and others that require mechanical circulatory support. AR is relatively common in LVAD patients and leads to poor outcomes, and this registry will provide the evidence needed to determine if transcatheter valve replacement can help this group of patients.” Dr. Uriel is Director of Advanced Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support at New York-Presbyterian in New York, New York.

JenaValve stated that the Trilogy THV system is used to treat symptomatic severe AR commercially in the European Union where it has received CE Mark approval and it is being evaluated in the ALIGN-AR investigational device exemption study and the ALIGN-AR continued-access protocol for patients at high risk for surgery. In these situations, patients with LVAD are excluded because of left ventricular fraction < 25% and other exclusions. As such, patients with LVAD have been treated under compassionate-use consideration in the United States and off-label in the European Union. The registry protocol will ensure consistency in performing the procedure, patient management, and documentation of results in this patient population, noted JenaValve.

In the United States, the Trilogy THV system is limited to investigation use only, advised the company.