Medical technology company LivaNova has completed enrollment for a global aortic valve replacement clinical trial comparing the benefits of sutureless versus standard aortic valve replacement for aortic stenosis.
Image: LivaNova completes enrollment for global aortic valve replacement clinical trial. Photo: courteys of Daino_16/FreeImages.com
The company welcomed the recently updated interventional procedures guidance for sutureless aortic valve replacement issued by the U.K. National Institute for Health and Care Excellence (NICE), which states that sutureless aortic valve replacement is an alternative to conventional surgical aortic valve replacement.
Based on its evaluation, NICE concludes that the sutureless aortic valve replacement procedure may be faster than the standard procedure, reducing cardiopulmonary and aortic cross-clamp times. Additionally, sufficient evidence was found to support the safety and efficacy of the sutureless procedure.
The guidance was informed by a comprehensive assessment of literature and detailed review of evidence from various sources, including six systematic reviews and meta-analyses and two case series. The review also included patient feedback and considered outcomes such as quality of life, valve durability and clinical improvements.
Concurrently, LivaNova completed enrollment for the Perceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) study with more than 900 patients from 47 centers in 12 countries. While the original study protocol was for 1,234 patients, the introduction of an innovative adaptive design allowed for a reduced sample size and the ability to analyze data earlier.
PERSIST-AVR, which began in April 2016, is the only worldwide, prospective, randomized, multi-center trial comparing the LivaNova Perceval sutureless aortic valve with standard sutured bioprostheses in patients with aortic valve disease.
The principal investigators for PERSIST-AVR are University Cardiovascular Center Paracelsus Medical Professor Theodor Fischlein and Maastricht University Medical Centre Cardio-Thoracic Surgery Department Professor Roberto Lorusso.
Fischlein said: “The speed of recruitment and global engagement is a solid statement for the adoption of Perceval around the world.”
Lorusso said: “This release of data will certainly support our daily experience of aortic valve replacement with Perceval.”
Since 2007, Perceval has been implanted in thousands of patients with aortic valve disease to help improve their lives.
LivaNova Cardiac Surgery general manager Alistair Simpson said: “Our Perceval sutureless aortic valve is one of our important growth drivers and continues to offer surgeons and patients a proven alternative with unique benefits compared to traditional aortic valve replacement.
“The updated NICE guidance and completion of our PERSIST-AVR clinical trial enrollment are key milestones that will support an even greater adoption rate.”
Company: Press Release.