JenaValve Completes First-Ever Implant in JENA-VAD Registry Evaluating Trilogy System for Severe Aortic Regurgitation in cfLVAD Patients

JenaValve Technology Announces First Patient Procedure Completed in the JENA-VAD Registry

JENA-VAD Registry is a prospective, multicenter, single-arm clinical registry nested within the ALIGN-AR study, evaluating the ability of the JenaValve Trilogy Heart Valve System device to safely and effectively treat severe symptomatic aortic regurgitation in patients with continuous-flow left ventricular assist devices (cfLVAD). The first case was completed at Cedars-Sinai Medical Center in Los Angeles, USA.

JenaValve CEO John Kilcoyne stated, "Our mission is to address the critical gap for one-third of patients using left ventricular assist devices (LVAD) who experience severe aortic regurgitation (AR) and face significant heart failure risks." "These patients have very limited treatment options, so with the Trilogy system, we aim to explore whether there could be a new path forward."

"We are excited to initiate the JENA-VAD Registry and take a meaningful step in exploring treatment options for a large number of AR patients," said Raj Makkar of Cedars-Sinai Medical Center, who performed the case and is one of the registry investigators. "The positive outcomes from the ALIGN-AR study provide a strong foundation and rationale for advancing this registry to investigate whether Transcatheter Aortic Valve Implantation (TAVI) with a dedicated device could be a solution for these severe AR patients. We look forward to the results of this registry."

The JenaValve Trilogy Heart Valve System device is commercially available for the treatment of symptomatic severe AR under the CE Mark in the European Union and is being evaluated in high-risk surgical patients within the ALIGN-AR IDE study and the ALIGN-AR CAP protocol.

In these cases, LVAD patients were excluded due to a left ventricular ejection fraction (LVEF) <25% and other exclusion criteria. As a result, LVAD patients received treatment under compassionate use in the United States and off-label treatment in the European Union. The registry protocol will ensure consistency in procedure implementation, patient management, and outcome documentation within this patient population.

"As a heart failure cardiologist, I focus on the sickest patients, including heart transplant patients and others who need mechanical circulatory support," said Nir Uriel, director of advanced heart failure, heart transplantation, and mechanical circulatory support at New York-Presbyterian Hospital, chairman of the JENA-VAD Registry, and the national principal investigator in China. "AR is relatively common in LVAD patients and leads to adverse outcomes, and this registry will provide the evidence needed to determine whether transcatheter valve replacement can help this group of patients."