Sorin has announced the initiation of PERSIST-AVR (Perceval sutureless implant vs. standard aortic valve replacement), which is the first international, prospective, post-market randomised multicentre trial evaluating the Perceval sutureless aortic valve compared to standard sutured bioprostheses in patients with aortic valve disease.
The PERSIST-AVR trial will be conducted at 60 sites worldwide where Perceval has obtained regulatory clearance. It is expected to recruit patients with severe symptomatic aortic stenosis or steno-insufficiency who are candidates for surgical replacement of their native aortic valve. The primary endpoint of the trial is to demonstrate non-inferiority of major adverse cardiac cerebrovascular Events (MACCE) at one year according to VARC-2 criteria. The study is expected to enrol 1,234 patients within a two-year enrolment period and patients will be followed until five years post procedure.
Roberto Lorusso (Maastricht University Medical Center, Maastricht, The Netherlands), principal co-investigator of the trial, says: “PERSIST-AVR is the first large international multicentre trial on surgical aortic valve replacement since thirty years. This trial will provide a unique opportunity to further understand the valve’s safety and efficacy and potentially establish Perceval as the new gold standard in the surgical treatment of aortic valve disease.”
A press release reports that the Perceval sutureless valve is engineered to restore and preserve natural valve performance in patients who require an aortic valve replacement. It adds that, as a new generation of aortic bioprostheses, the valve offers potential patient advantages including reduced ICU stay, ventilation time, and need for blood transfusion compared to traditional sutured valves.