PERSIST-AVRPerceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease
Perceval valve
+ other stented biological valve
Aortic Valve Disease+3
+ Aortic Valve Stenosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: March 22, 2016
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.914 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. The subject has an indication for treatment by valve replacement with a bioprosthesis according to the IFU, through either full sternotomy or mini-sternotomy. 2. The subject has aortic valve disease that can be treated with a commercially available Perceval valve size, based on preoperative CT-scan. 3. The subject has: 1. critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index \< 0.6 cm2/m2 AND 2. Mean gradient \> 40 mmHg or Vmax \> 4 m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization \[or with dobutamine stress, if subject has a left ventricular ejection fraction (LVEF) \<55%\] or velocity ratio \< 0.25; 4. The subject is symptomatic due to aortic stenosis with functional class of New York Heart Association (NYHA) II or higher. 5. The subject has signed the informed consent. 6. The subject is of legal minimum age. 7. The subject will be available for postoperative follow-up beyond one year. Exclusion Criteria: 1. The subject has a contraindication for treatment by the Perceval valve or by a bioprosthetic aortic valve as stated in the IFU. 2. The subject has aneurismal dilation or dissection of the ascending aortic wall. 3. The subject is scheduled for concomitant procedures other than Coronary Aortic Bypass Graft (CABG), myectomy with or without aortic annulus enlargement 4. The subject has congenital bicuspid (i.e. Sievers type 0) or unicuspid aortic valve. 5. Anatomical structures not suitable for Perceval valve such as: aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter is \> 1.3. 6. The subject has a prosthetic heart valve in any position, including mitral valve repair. 7. The subject has a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days prior to the planned valve implant surgery. 8. The subject has active endocarditis, myocarditis, or sepsis. 9. The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support. 10. The subject is allergic to nickel alloys. 11. The subject is already included in another clinical trial that could confound the results of this clinical investigation.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 47 locations
St. Vincent Heart Center of Indiana
Indianapolis, United StatesMaine Medical Center
Portland, United StatesHeart and Vascular Institute, Cleveland Clinic
Cleveland, United States