Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR)

March 5, 2024 updated by: Corcym S.r.l

Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

914

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Klinische Abteilung fuer Herzchirurgie
      • Innsbruck, Austria
        • Medical University of Innsbruck
      • Vienna, Austria
        • Medical University of Vienna
      • Wien, Austria
        • Herzzentrum Hietzing
  • Belgium
      • Antwerp, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Bruxelles, Belgium
        • Cliniques Univ. Saint-Luc
      • Leuven, Belgium
        • Universitair Ziekenhuis
  • Canada
      • Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
    • Alberta
      • Edmonton, Alberta, Canada, 2H234
        • University of Alberta
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • Chile
      • Santiago, Chile
        • Hospital Clinico San Borja Arriarán
  • France
      • Angers, France, 49000
        • Chu Angers
      • Besançon, France
        • C.H.U. de Besançon
      • Bois Bernard, France
        • Hôpital privé de Bois Bernard
      • Lille, France
        • CHRU de Lille
      • Montpellier, France, 34295
        • CHU Arnaud de Villeneuve
      • Nancy, France
        • C.H.U. de Nancy
      • Poitiers, France
        • CHU De Poitiers
  • Germany
      • Bad Krozingen, Germany
        • Herzzentrum Bad Krozingen
      • Bad Neustadt An Der Saale, Germany
        • Herz- und Gefäß-Klinik
      • Dresden, Germany, 1307
        • Herzzentrum Dresden GmbH Universitätsklinik
      • Hamburg, Germany, D- 21075
        • Asklepios Klinikum Harburg
      • Hamburg, Germany, D-20246
        • University Heart Center Hamburg
      • Hannover, Germany
        • Medizinische Hochschule
      • Nürnberg, Germany
        • Klinikum Nürnberg
  • Israel
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Tel Aviv, Israel
        • Sheba Medical Center
  • Italy
      • Brescia, Italy
        • Spedali Civili
      • Cotignola, Italy
        • Maria Cecilia Hospital
      • Mantova, Italy
        • Azienda Ospedaliera Carlo Poma
    • BS
      • Brescia, BS, Italy, 25124
        • Fondazione Poliambulanza Istituto Ospedaliero
    • CT
      • Pedara, CT, Italy, 95030
        • Centro Cuore Morgagni Pedara
    • MI
      • Milan, MI, Italy, 20132
        • Ospedale San Raffaele
      • Milan, MI, Italy, 20149
        • lstituto Clinico Sant'Ambrogio e San Siro
    • MS
      • Massa, MS, Italy, 54100
        • Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Maastricht, Netherlands
        • Maastricht University Hospital
  • Spain
      • A Coruna, Spain, 15009
        • Complejo Hospitalario Universitario de A Coruña
      • Badalona, Spain
        • Hospital University Germans Trias i Pujol
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca
  • United Kingdom
      • Blackpool, United Kingdom
        • Victoria Hospital
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Heart Center of Indiana
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Heart and Vascular Institute, Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute, Houston Methodist Hospital
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Valley Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perceval
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.
Device: Perceval valve
Sutureless Aortic Biological Valve
Active Comparator: other Stented biological valves
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.
Device: other stented biological valve
Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame: 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.
1 year post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Times
Time Frame: 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
Intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcym S.r.l

Investigators

  • Principal Investigator: Theodor Fischlein, MD, Klinikum Nurnberg, Nurnberg, Germany
  • Principal Investigator: Roberto Lorusso, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2016

Primary Completion (Actual)

January 17, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimated)

February 4, 2016

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPS003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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