Last updated on October 2018

Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

Brief description of study

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study.

A minimum of 1234 subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available.

The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

Detailed Study Description

PERSIST-AVR is designed to collect data on sutureless valve (Perceval sutureless aortic heart valve), a new type of biological aortic valve, comparing data with standard biological aortic valve, considered the gold standard for aortic valve replacement. This prospective, randomized international multicenter study is planned to demonstrate, as primary endpoint, the non inferiority of Major Adverse Cardiac and Cerebrovascular (MACCE) events at one year while showing superiority in resource consumptions at hospital discharge in patients treated with Perceval valve when compared to standard aortic valve replacement. The study is planned to cover the lack of prospective, randomized comparison data between sutureless valve and standard aortic biological sutured valve. To achieve the primary endpoint, 1234 patients will be recruited in 60 worldwide investigational sites. The be part of the trial, investigational sites should have demonstrated experience with the implantation of the Perceval and able to implement the requirements of the study protocol.. 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 will be 7 years

Clinical Study Identifier: NCT02673697

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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