Medical device firm Sorin Group has commenced the first international, prospective, post-market and randomized multi-center trial, which evaluates the Perceval sutureless aortic valve compared to standard sutured bioprostheses in patients with aortic valve disease.
The perceval sutureless implant Vs standard aortic valve replacement (PERSIST-AVR) study will be carried out at 60 sites across the world where Perceval obtained regulatory approval.
Perceval, which is a sutureless heart valve for patients who require an aortic valve replacement, provides patient advantages such as reduced ICU stay, ventilation time, and need for blood transfusion compared to traditional sutured valves.
The study principal investigator Dr 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 study, the firm will enroll patients with severe symptomatic aortic stenosis or steno-insufficiency, who are candidates for surgical replacement of their native aortic valve.
The company will enroll around 1,234 patients within a two-year enrollment period and will be followed for five years, after the procedure.
According to the firm, the primary endpoint of the study is to demonstrate 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."