Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

NCT ID: NCT02673697

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 914 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-22
• Study Completion Date: 2020-07-31

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.

Conditions

Aortic Valve Disease; Aortic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Perceval valve

Intervention Type: DEVICE

Sutureless Aortic Biological Valve

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.

Group Type: ACTIVE_COMPARATOR

other stented biological valve

Intervention Type: DEVICE

Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)

Interventions

Perceval valve

Sutureless Aortic Biological Valve

Intervention Type: DEVICE

other stented biological valve

Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corcym S.r.l

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodor Fischlein, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Nurnberg, Nurnberg, Germany

Roberto Lorusso, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 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

Valley Health System

Winchester, Virginia, United States

Klinische Abteilung fuer Herzchirurgie

Graz, , Austria

Medical University of Innsbruck

Innsbruck, , Austria

Herzzentrum Hietzing

Vienna, , Austria

Medical University of Vienna

Vienna, , Austria

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Cliniques Univ. Saint-Luc

Brussels, , Belgium

Universitair Ziekenhuis

Leuven, , Belgium

University of Alberta

Edmonton, Alberta, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, , 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

Chru De Lille

Lille, , France

CHU Arnaud de Villeneuve

Montpellier, , France

C.H.U. de Nancy

Nancy, , 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

Hanover, , Germany

Klinikum Nürnberg

Nuremberg, , Germany

Shaare Zedek Medical Center

Jerusalem, , Israel

Sheba medical Center

Tel Aviv, , Israel

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, BS, Italy

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

Azienda Ospedaliera Carlo Poma

Mantova, , Italy

Catharina Ziekenhuis

Eindhoven, , Netherlands

Maastricht University Hospital

Maastricht, , Netherlands

Complejo Hospitalario Universitario De A Coruña

A Coruña, , Spain

Hospital University Germans Trias I Pujol

Badalona, , Spain

Hospital Clinico Universitario Virgen De La Arrixaca

Murcia, , Spain

Victoria Hospital

Blackpool, , United Kingdom

Countries

United States; Austria; Belgium; Canada; Chile; France; Germany; Israel; Italy; Netherlands; Spain; United Kingdom

References

Lorusso R, Folliguet T, Shrestha M, Meuris B, Kappetein AP, Roselli E, Klersy C, Nozza M, Verhees L, Larracas C, Goisis G, Fischlein T. Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design. Thorac Cardiovasc Surg. 2020 Mar;68(2):114-123. doi: 10.1055/s-0038-1675847. Epub 2018 Nov 29.

Reference Type: BACKGROUND

PMID: 30497085 (View on PubMed)

Fischlein T, Folliguet T, Meuris B, Shrestha ML, Roselli EE, McGlothlin A, Kappert U, Pfeiffer S, Corbi P, Lorusso R; Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement Investigators. Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis. J Thorac Cardiovasc Surg. 2021 Mar;161(3):920-932. doi: 10.1016/j.jtcvs.2020.11.162. Epub 2020 Dec 14.

Reference Type: RESULT

PMID: 33478837 (View on PubMed)

Lorusso R, Ravaux JM, Pollari F, Folliguet TA, Kappert U, Meuris B, Shrestha ML, Roselli EE, Bonaros N, Fabre O, Corbi P, Troise G, Andreas M, Pinaud F, Pfeiffer S, Kueri S, Tan E, Voisine P, Girdauskas E, Rega F, Garcia-Puente J, Fischlein T; on behalf the PERSIST-AVR Investigators. Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial. Eur J Cardiothorac Surg. 2022 Sep 2;62(4):ezac164. doi: 10.1093/ejcts/ezac164.

Reference Type: DERIVED

PMID: 35290444 (View on PubMed)

Lorusso R, Jiritano F, Roselli E, Shrestha M, Folliguet T, Meuris B, Pollari F, Fischlein T; PERSIST-AVR Investigators. Perioperative platelet reduction after sutureless or stented valve implantation: results from the PERSIST-AVR controlled randomized trial. Eur J Cardiothorac Surg. 2021 Dec 1;60(6):1359-1365. doi: 10.1093/ejcts/ezab175.

Reference Type: DERIVED

PMID: 34118150 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TPS003

Identifier Type: -

Identifier Source: org_study_id