Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

Not Applicable

Terminated

Conditions: Aortic Valve Disease
Aortic Stenosis

Interventions: Device: other stented biological valve
Device: Perceval valve

Registration Number: NCT02673697

Lead Sponsor: Corcym S.r.l

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 914

Inclusion Criteria

The subject has an indication for treatment by valve replacement with a bioprosthesis according to the IFU, through either full sternotomy or mini-sternotomy.
The subject has aortic valve disease that can be treated with a commercially available Perceval valve size, based on preoperative CT-scan.
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;
The subject is symptomatic due to aortic stenosis with functional class of New York Heart Association (NYHA) II or higher.
The subject has signed the informed consent.
The subject is of legal minimum age.
The subject will be available for postoperative follow-up beyond one year.

Exclusion Criteria

The subject has a contraindication for treatment by the Perceval valve or by a bioprosthetic aortic valve as stated in the IFU.
The subject has aneurismal dilation or dissection of the ascending aortic wall.
The subject is scheduled for concomitant procedures other than Coronary Aortic Bypass Graft (CABG), myectomy with or without aortic annulus enlargement
The subject has congenital bicuspid (i.e. Sievers type 0) or unicuspid aortic valve.
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.
The subject has a prosthetic heart valve in any position, including mitral valve repair.
The subject has a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days prior to the planned valve implant surgery.
The subject has active endocarditis, myocarditis, or sepsis.
The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support.
The subject is allergic to nickel alloys.
The subject is already included in another clinical trial that could confound the results of this clinical investigation.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
other Stented biological valves	other stented biological valve	The comparator will be other commercially approved standard biological sutured stented valves, both bovine and porcine. The choice of the comparator tissue valve will be at the discretion of the participating investigators.
Perceval	Perceval valve	The Perceval sutureless aortic heart valve (Perceval valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The Perceval valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)	1 year post-operatively	The primary endpoint is freedom from MACCE (composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention) at one year based on Clinical Event Committee (CEC) adjudication.

Secondary Outcome Measures

Name	Time	Method
Surgical Times	Intra-operative	1. Cross clamp time during index procedure 2. Cardiopulmonary bypass time during index procedure Start time and finish time were collected for operative room time procedure and calculated for each subject. Mean was calculated and reported in the results sections

Trial Locations

Locations (47): C.H.U. de Nancy
🇫🇷
Nancy, France
Chru De Lille
🇫🇷
Lille, France
Valley Health System
🇺🇸
Winchester, Virginia, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Heart and Vascular Institute, Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Houston Methodist Research Institute, Houston Methodist Hospital
🇺🇸
Houston, Texas, United States
Southlake Regional Health Centre
🇨🇦
Newmarket, Ontario, Canada
St. Vincent Heart Center of Indiana
🇺🇸
Indianapolis, Indiana, United States
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
🇨🇦
Quebec, Canada
Hospital Clinico San Borja Arriaran
🇨🇱
Santiago, Chile
CHU Angers
🇫🇷
Angers, France
C.H.U. de Besançon
🇫🇷
Besançon, France
Hôpital privé de Bois Bernard
🇫🇷
Bois Bernard, France
CHU Arnaud de Villeneuve
🇫🇷
Montpellier, France
CHU de Poitiers
🇫🇷
Poitiers, France
Herzzentrum Bad Krozingen
🇩🇪
Bad Krozingen, Germany
Herz- und Gefäß-Klinik
🇩🇪
Bad Neustadt An Der Saale, Germany
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪
Dresden, Germany
ASKLEPIOS Klinikum Harburg
🇩🇪
Hamburg, Germany
University Heart Center Hamburg
🇩🇪
Hamburg, Germany
Medizinische Hochschule
🇩🇪
Hannover, Germany
Klinikum Nürnberg
🇩🇪
Nürnberg, Germany
Sheba medical Center
🇮🇱
Tel Aviv, Israel
Fondazione Poliambulanza Istituto Ospedaliero
🇮🇹
Brescia, BS, Italy
Complejo Hospitalario Universitario De A Coruña
🇪🇸
A Coruna, Spain
Azienda Ospedaliera Carlo Poma
🇮🇹
Mantova, Italy
Hospital University Germans Trias I Pujol
🇪🇸
Badalona, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
🇪🇸
Murcia, Spain
Victoria Hospital
🇬🇧
Blackpool, United Kingdom
Maastricht University Hospital
🇳🇱
Maastricht, Netherlands
Klinische Abteilung fuer Herzchirurgie
🇦🇹
Graz, Austria
Herzzentrum Hietzing
🇦🇹
Wien, Austria
Universitair Ziekenhuis Antwerpen
🇧🇪
Antwerp, Belgium
Catharina Ziekenhuis
🇳🇱
Eindhoven, Netherlands
Shaare Zedek Medical Center
🇮🇱
Jerusalem, Israel
Medical University of Innsbruck
🇦🇹
Innsbruck, Austria
Medical University of Vienna
🇦🇹
Vienna, Austria
Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Cliniques Univ. Saint-Luc
🇧🇪
Bruxelles, Belgium
Universitair Ziekenhuis
🇧🇪
Leuven, Belgium
University of Alberta
🇨🇦
Edmonton, Alberta, Canada
Centro Cuore Morgagni Pedara
🇮🇹
Pedara, CT, Italy
Ospedale San Raffaele
🇮🇹
Milan, MI, Italy
lstituto Clinico Sant'Ambrogio e San Siro
🇮🇹
Milan, MI, Italy
Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
🇮🇹
Massa, MS, Italy
Spedali Civili
🇮🇹
Brescia, Italy
Maria Cecilia Hospital
🇮🇹
Cotignola, Italy