Clinical trial NCT02673697: Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Official title: Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Disease
Aortic Stenosis
Keywords: Sutureless valve
Lead sponsor: Corcym S.r.l
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 914
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 1 year post-operatively
Secondary outcomes:
measure: Surgical Times
timeFrame: Intra-operative
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Cleveland
country: United States
facility: Heart and Vascular Institute, Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: Houston Methodist Research Institute, Houston Methodist Hospital
state: Texas
city: Winchester
country: United States
facility: Valley Health System
state: Virginia
city: Graz
country: Austria
facility: Klinische Abteilung fuer Herzchirurgie
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Wien
country: Austria
facility: Herzzentrum Hietzing
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bruxelles
country: Belgium
facility: Cliniques Univ. Saint-Luc
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
city: Santiago
country: Chile
facility: Hospital Clinico San Borja Arriaran
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: C.H.U. de Besançon
city: Bois Bernard
country: France
facility: Hôpital privé de Bois Bernard
city: Lille
country: France
facility: Chru De Lille
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Nancy
country: France
facility: C.H.U. de Nancy
city: Poitiers
country: France
facility: CHU de Poitiers
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Neustadt An Der Saale
country: Germany
facility: Herz- und Gefäß-Klinik
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Hamburg
country: Germany
facility: ASKLEPIOS Klinikum Harburg
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Tel Aviv
country: Israel
facility: Sheba medical Center
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
state: BS
city: Pedara
country: Italy
facility: Centro Cuore Morgagni Pedara
state: CT
city: Milan
country: Italy
facility: Ospedale San Raffaele
state: MI
city: Milan
country: Italy
facility: lstituto Clinico Sant'Ambrogio e San Siro
state: MI
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
state: MS
city: Brescia
country: Italy
facility: Spedali Civili
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario De A Coruña
city: Badalona
country: Spain
facility: Hospital University Germans Trias I Pujol
city: Murcia
country: Spain
facility: Hospital Clinico Universitario Virgen De La Arrixaca
city: Blackpool
country: United Kingdom
facility: Victoria Hospital
Study officials:
affiliation: Klinikum Nurnberg, Nurnberg, Germany
name: Theodor Fischlein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Roberto Lorusso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.