PERSIST-AVR

• Research type

  Research Study

• Full title

  Perceval Sutureless Implant Vs Standard Aortic Valve Replacement. A Controlled Randomized Trial in the surgical treatment of Aortic Valve disease.

• IRAS ID

  199441

• Contact name

  Russel Millner

• Contact email

  Mr.Millner@bfwhospitals.nhs.uk

• Sponsor organisation

  Sorin Group Italia

• Clinicaltrials.gov Identifier

  NCT02673697

• Duration of Study in the UK

  6 years, 2 months, 30 days

• Research summary

  PERSIST-AVR is designed to collect data on sutureless valve (Perceval sutureless aortic heart valve), a new type of biological aortic valve in a metallic cage that supports the valve and keeps the valve in place without the need for sutures. The comparison group is standard biological aortic valve, considered the gold standard for aortic valve replacement, that need to be sewed in place.
  The study is designed as a prospective, randomized multicenter study. The goal is to demonstrate the non inferiority of Major Adverse Cardiac and Cerebrovascular Events (MACCE) events at one year. MACCE is defined as a composite endpoint of all causes of deaths, stroke, myocardial infarction and valve re-intervention (valve explants). As secondary endpoint the trial would like to show superiority in resource consumptions index at hospital discharge. This index is including health economics data about all the cost related to the surgery.
  The study is planned to cover the lack of prospective, randomized comparison data between sutureless valve and standard aortic biological sutured valve in the current published literature.
  To achieve the primary endpoint, 1234 patients will be recruited in 60 worldwide investigational sites.
  All subjects with severe symptomatic aortic stenosis or steno-insufficiency who are candidates for surgical replacement of their native aortic valve according to established guidelines in current medical practice and as specified in the Perceval valve Instruction For Use (IFU) are the intended population for inclusion in this randomized trial.
  The patients will be followed for 5 years after the implant, the total duration of study including the enrollment time of 2 years will be 7 years

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  16/NW/0293

• Date of REC Opinion

  22 Jun 2016

• REC opinion

  Further Information Favourable Opinion