LivaNova announces first patient enrollment in PERFECT trial in China
LivaNova has announced the first patient enrollment in the Perceval Valve Clinical study for Chinese Registration, or PERFECT, Trial. The study is a pre-market, prospective, single-arm trial. The PERFECT trial is being conducted to demonstrate the safety and effectiveness of the Perceval sutureless aortic heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement. The PERFECT trial is expected to enroll approximately 160 patients who will receive five years of follow-up at eight investigational sites in China. The primary endpoint of the trial is a one-year composite endpoint of major cardiac events as per the Clinical Events Committee adjudication.