JenaValve Technology has announced the successful completion of patient enrolment in the ALIGN-AR Pivotal trial, a landmark prospective, single-arm investigation device exemption (IDE) study designed to assess the safety and efficacy of the Trilogy transcatheter aortic valve implantation (TAVI) system in high-risk patients with symptomatic, severe aortic regurgitation (ssAR).
Results from the study are intended to support a future premarket approval (PMA) submission to the US Food and Drug Administration (FDA).
“Completing the ALIGN-AR trial is a significant step forward for the cardiology community in addressing an unmet need for patients suffering from significant AR,” said Martin B Leon (Columbia University Irving Medical Center, New York, USA) global programme chair for the trial. “The unique design of the Trilogy system has the potential to address the shortcomings of existing TAVI devices when treating high surgical risk AR patients, enabling physicians to address a critical and long-overdue need for a minimally invasive solution that can meaningfully improve a patient’s quality of life.”
“This is a potentially game-changing clinical trial for the treatment of ssAR in a significant patient population which has not been addressed by other solutions,” said Raj Makkar (Cedars-Sinai Medical Center, Los Angeles, USA) leading enroller for the trial. “If approved, the Trilogy System will be the only transcatheter device indicated for the treatment of ssAR patients, with a potential to become the standard of care for these patients.”