Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02673697
Status:
TERMINATED
Last Update Posted:
2024-03-06
First Post:
2016-01-21
Brief Title:
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Sponsor:
Corcym Srl
Organization:
Corcym Srl
Study Overview
Official Title:
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERSIST-AVR
Brief Summary:
Prospective randomized stratified non blinded multi-center international post market trial assessed in a non-inferiority study
The trial has a flexible sample size that will be determined adaptively The trial will enroll up to 1234 subjects but accrual may stop earlier at approximately 900 or 1050 subjects These 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
The trial has a flexible sample size that will be determined adaptively The trial will enroll up to 1234 subjects but accrual may stop earlier at approximately 900 or 1050 subjects These 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 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 The trial has a flexible sample size that will be determined adaptively The trial will enroll up to 1234 subjects but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary endpoint will be reached at 1 year FU and consequently the planned primary analysis will be performed 12 months following the end of accrual
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None