JenaValve Technology has announced the completion of the first patient procedure for inclusion in the JENA-VAD registry.
The JENA-VAD registry is a prospective, multicentre, single arm clinical registry nested within the ALIGN-AR study evaluating the ability of the JenaValve Trilogy heart valve system device to treat severe symptomatic aortic regurgitation safely and effectively in patients with a continuous flow left ventricular assist device (cfLVAD). The first case was completed at Cedars-Sinai Medical Center in Los Angeles, USA.
“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,” said John Kilcoyne, CEO of JenaValve. “These patients have very limited treatment options, so with the Trilogy system, we seek to understand whether there can be a new pathway forward.”
“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,” said Raj Makkar, Cedars-Sinai Medical Center, who performed the case and is one of the registry investigators. “The positive results of the ALIGN-AR study provide a strong base and justification for moving forward with this registry studying whether transcatheter aortic valve implantation (TAVI) with a dedicated device may be a solution for these patients with significant AR. We look forward to the results of this registry.”
The JenaValve Trilogy heart valve system device is used to treat symptomatic severe AR commercially in the EU under CE mark and is being evaluated in the ALIGN-AR IDE study and ALIGN-AR CAP protocol for patients at high-risk for surgery.
In these situations, patients with LVAD are excluded because of left ventricular fraction (LVEF) <25% and other exclusions. As such, patients with LVAD have been treated under compassionate use consideration in the USA and off-label in the EU. The registry protocol will ensure consistency in performing the procedure, patient management, and documentation of results in this patient population.
“As a heart failure cardiologist, I focus on very sick patients including heart transplant patients and others that require mechanical circulatory support,” said Nir Uriel, director of advanced heart failure, cardiac transplantation and mechanical circulatory support at New York-Presbyterian, and chair and national principal investigator of the JENA-VAD registry. “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.”
