Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

Aortic Stenosis Clinical Trial

— PERSIST-AVR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02673697
• Other study ID #: TPS003
• Status: Terminated
• Phase: N/A
• Start date: March 22, 2016
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2024
• Source: Corcym S.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 914
• Est. completion date: July 31, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Disease
• Aortic Valve Stenosis

Intervention

Device:
• Perceval valve
Sutureless Aortic Biological Valve
• other stented biological valve
Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)

Locations

Country	Name	City	State
Austria	Klinische Abteilung fuer Herzchirurgie	Graz
Austria	Medical University of Innsbruck	Innsbruck
Austria	Medical University of Vienna	Vienna
Austria	Herzzentrum Hietzing	Wien
Belgium	Universitair Ziekenhuis Antwerpen	Antwerp
Belgium	Cliniques Univ. Saint-Luc	Bruxelles
Belgium	Universitair Ziekenhuis	Leuven
Canada	University of Alberta	Edmonton	Alberta
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval	Quebec
Chile	Hospital Clinico San Borja Arriaran	Santiago
France	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
Germany	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
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Sheba medical Center	Tel Aviv
Italy	Fondazione Poliambulanza Istituto Ospedaliero	Brescia	BS
Italy	Spedali Civili	Brescia
Italy	Maria Cecilia Hospital	Cotignola
Italy	Azienda Ospedaliera Carlo Poma	Mantova
Italy	Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa	Massa	MS
Italy	lstituto Clinico Sant'Ambrogio e San Siro	Milan	MI
Italy	Ospedale San Raffaele	Milan	MI
Italy	Centro Cuore Morgagni Pedara	Pedara	CT
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Maastricht University Hospital	Maastricht
Spain	Complejo Hospitalario Universitario De A Coruña	A Coruna
Spain	Hospital University Germans Trias I Pujol	Badalona
Spain	Hospital Clinico Universitario Virgen De La Arrixaca	Murcia
United Kingdom	Victoria Hospital	Blackpool
United States	Heart and Vascular Institute, Cleveland Clinic	Cleveland	Ohio
United States	Houston Methodist Research Institute, Houston Methodist Hospital	Houston	Texas
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Maine Medical Center	Portland	Maine
United States	Valley Health System	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Corcym S.r.l

Countries where clinical trial is conducted

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

References & Publications (2)

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 aort — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical Times	Cross clamp time during index procedure; 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