Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

NCT02673697 | Terminated Results DMC

• 1 other identifier: TPS003
• Study Type: interventional
• Target: 914
• Locations: 12 countries
• Sites: 47

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.

Conditions

Aortic Valve Disease; Aortic Stenosis

Keywords

Sutureless valve

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  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 Outcomes (1)

• Surgical Times

  Intra-operative

Study Arms (2)

Perceval

EXPERIMENTAL

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

other Stented biological valves

ACTIVE COMPARATOR

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

Interventions

Perceval valve DEVICE

Sutureless Aortic Biological Valve

Perceval

other stented biological valve DEVICE

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

other Stented biological valves

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corcym S.r.l: lead

Study Sites (47)

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Heart and Vascular Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Houston Methodist Research Institute, Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Valley Health System

Winchester, Virginia, 22601, United States

Location

Klinische Abteilung fuer Herzchirurgie

Graz, Austria

Location

Medical University of Innsbruck

Innsbruck, Austria

Location

Herzzentrum Hietzing

Vienna, Austria

Location

Medical University of Vienna

Vienna, Austria

Location

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

Location

Cliniques Univ. Saint-Luc

Brussels, Belgium

Location

Universitair Ziekenhuis

Leuven, Belgium

Location

University of Alberta

Edmonton, Alberta, 2H234, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

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

Québec, G1V 4G5, Canada

Location

Hospital Clinico San Borja Arriaran

Santiago, Chile

Location

CHU Angers

Angers, 49000, France

Location

C.H.U. de Besançon

Besançon, France

Location

Hôpital privé de Bois Bernard

Bois-Bernard, France

Location

Chru De Lille

Lille, France

Location

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

C.H.U. de Nancy

Nancy, France

Location

CHU de Poitiers

Poitiers, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Herz- und Gefäß-Klinik

Bad Neustadt an der Saale, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik

Dresden, 1307, Germany

Location

ASKLEPIOS Klinikum Harburg

Hamburg, D- 21075, Germany

Location

University Heart Center Hamburg

Hamburg, D-20246, Germany

Location

Medizinische Hochschule

Hanover, Germany

Location

Klinikum Nürnberg

Nuremberg, Germany

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Sheba medical Center

Tel Aviv, Israel

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, BS, 25124, Italy

Location

Centro Cuore Morgagni Pedara

Pedara, CT, 95030, Italy

Location

Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

lstituto Clinico Sant'Ambrogio e San Siro

Milan, MI, 20149, Italy

Location

Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa

Massa, MS, 54100, Italy

Location

Spedali Civili

Brescia, Italy

Location

Maria Cecilia Hospital

Cotignola, Italy

Location

Azienda Ospedaliera Carlo Poma

Mantova, Italy

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maastricht University Hospital

Maastricht, Netherlands

Location

Complejo Hospitalario Universitario De A Coruña

A Coruña, 15009, Spain

Location

Hospital University Germans Trias I Pujol

Badalona, Spain

Location

Hospital Clinico Universitario Virgen De La Arrixaca

Murcia, 30120, Spain

Location

Victoria Hospital

Blackpool, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 30497085 BACKGROUND

• 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.

  PMID: 33478837 RESULT

• 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.

  PMID: 35290444 DERIVED

• 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.

  PMID: 34118150 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Elisa Cerutti
• Organization: Corcym

elisa.cerutti@corcym.com

+39 3459182413

Study Officials

• Theodor Fischlein, MD

  Klinikum Nurnberg, Nurnberg, Germany

  PRINCIPAL INVESTIGATOR

• Roberto Lorusso, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 4, 2016
• Study Start: March 22, 2016
• Primary Completion: January 17, 2020
• Study Completion: July 31, 2020
• Last Updated: March 6, 2024
• Results First Posted: July 27, 2022

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); US (5); AU (4); BE (3); CL (1); DE (7); CA (4); FR (7); IT (8); ES (3); GB (1); NL (2)