Italy-based Sorin Group has started the first international, prospective, post-market and randomised multi-centre trial (PERSIST-AVR) that compares the Perceval sutureless aortic valve with the standard sutured bioprostheses in patients with aortic valve disease.
The perceval sutureless implant Vs standard aortic valve replacement study, PERSIST-AVR will be carried out at 60 sites worldwide where Perceval secured regulatory approval.
A sutureless heart valve for patients who require an aortic valve replacement, Perceval provides patient advantages such as reduced ICU stay, ventilation time, and need for blood transfusion compared to traditional sutured valves.
Paracelsus Medical University Cardiovascular Center professor and the study principal investigator Theodor Fischlein said: "To date, the Perceval valve has demonstrated very promising performances, freedom from structural valve deterioration, improved patient postoperative outcome results and significant cost savings driven by reduced hospital stays and lower procedural expenses."
In the trial, the company will enrol patients with severe symptomatic aortic stenosis or steno-insufficiency, who are candidates for surgical replacement of their native aortic valve.
Maastricht University Medical Center and the study principal co-investigator Dr Roberto Lorusso said: "PERSIST-AVR is the first large international multicenter trial on surgical aortic valve replacement for 30 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 total of 1,234 patients are expected to be enrolled in the trial within a two-year enrolment period and will be followed for five years, after the procedure.
The trial's primary endpoint is to show non-inferiority of major adverse cardiac cerebrovascular events (MACCE) at one year according to VARC-2 criteria.
Sorin Group cardiac surgery business unit president Michel Darnaud said: "We are pleased to announce the initiation of the international PERSIST-AVR trial, the first trial of its kind."
"While prior clinical trials on Perceval have demonstrated a reduction in patient hospital stays and improved patient outcomes, PERSIST-AVR is expected to give further evidence of Perceval compared to standard sutured stented bioprosthetic aortic valves."