Back to resultsPerceval Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR)
Primary Purpose
Aortic Valve Disease, Aortic Stenosis
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Perceval valve
other stented biological valve
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease focused on measuring Sutureless valve
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- St. Vincent Heart Center of Indiana
- Maine Medical Center
- Heart and Vascular Institute, Cleveland Clinic
- Houston Methodist Research Institute, Houston Methodist Hospital
- Valley Health System
- Klinische Abteilung fuer Herzchirurgie
- Medical University of Innsbruck
- Medical University of Vienna
- Herzzentrum Hietzing
- Universitair Ziekenhuis Antwerpen
- Cliniques Univ. Saint-Luc
- Universitair Ziekenhuis
- University of Alberta
- Southlake Regional Health Centre
- Montreal Heart Institute
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
- Hospital Clinico San Borja Arriaran
- CHU Angers
- C.H.U. de Besançon
- Hôpital privé de Bois Bernard
- Chru De Lille
- CHU Arnaud de Villeneuve
- C.H.U. de Nancy
- CHU de Poitiers
- Herzzentrum Bad Krozingen
- Herz- und Gefäß-Klinik
- Herzzentrum Dresden GmbH Universitätsklinik
- ASKLEPIOS Klinikum Harburg
- University Heart Center Hamburg
- Medizinische Hochschule
- Klinikum Nürnberg
- Shaare Zedek Medical Center
- Sheba medical Center
- Fondazione Poliambulanza Istituto Ospedaliero
- Centro Cuore Morgagni Pedara
- Ospedale San Raffaele
- lstituto Clinico Sant'Ambrogio e San Siro
- Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
- Spedali Civili
- Maria Cecilia Hospital
- Azienda Ospedaliera Carlo Poma
- Catharina Ziekenhuis
- Maastricht University Hospital
- Complejo Hospitalario Universitario De A Coruña
- Hospital University Germans Trias I Pujol
- Hospital Clinico Universitario Virgen De La Arrixaca
- Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Perceval
other Stented biological valves
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02673697
Brief Title
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Acronym
PERSIST-AVR
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
March 22, 2016 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcym S.r.l
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Aortic Stenosis
Keywords
Sutureless valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
914 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perceval
Arm Type
Experimental
Arm Description
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.
Arm Title
other Stented biological valves
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Perceval valve
Intervention Description
Sutureless Aortic Biological Valve
Intervention Type
Device
Intervention Name(s)
other stented biological valve
Intervention Description
Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
Primary Outcome Measure Information:
Title
Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Description
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.
Time Frame
1 year post-operatively
Secondary Outcome Measure Information:
Title
Surgical Times
Description
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
Time Frame
Intra-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodor Fischlein, MD
Organizational Affiliation
Klinikum Nurnberg, Nurnberg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Lorusso, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Heart and Vascular Institute, Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Houston Methodist Research Institute, Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Health System
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Klinische Abteilung fuer Herzchirurgie
City
Graz
Country
Austria
Facility Name
Medical University of Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Name
Herzzentrum Hietzing
City
Wien
Country
Austria
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Cliniques Univ. Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
Universitair Ziekenhuis
City
Leuven
Country
Belgium
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
2H234
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Hospital Clinico San Borja Arriaran
City
Santiago
Country
Chile
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
C.H.U. de Besançon
City
Besançon
Country
France
Facility Name
Hôpital privé de Bois Bernard
City
Bois Bernard
Country
France
Facility Name
Chru De Lille
City
Lille
Country
France
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
C.H.U. de Nancy
City
Nancy
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Herz- und Gefäß-Klinik
City
Bad Neustadt An Der Saale
Country
Germany
Facility Name
Herzzentrum Dresden GmbH Universitätsklinik
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
ASKLEPIOS Klinikum Harburg
City
Hamburg
ZIP/Postal Code
D- 21075
Country
Germany
Facility Name
University Heart Center Hamburg
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Medizinische Hochschule
City
Hannover
Country
Germany
Facility Name
Klinikum Nürnberg
City
Nürnberg
Country
Germany
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Sheba medical Center
City
Tel Aviv
Country
Israel
Facility Name
Fondazione Poliambulanza Istituto Ospedaliero
City
Brescia
State/Province
BS
ZIP/Postal Code
25124
Country
Italy
Facility Name
Centro Cuore Morgagni Pedara
City
Pedara
State/Province
CT
ZIP/Postal Code
95030
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milan
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
lstituto Clinico Sant'Ambrogio e San Siro
City
Milan
State/Province
MI
ZIP/Postal Code
20149
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
City
Massa
State/Province
MS
ZIP/Postal Code
54100
Country
Italy
Facility Name
Spedali Civili
City
Brescia
Country
Italy
Facility Name
Maria Cecilia Hospital
City
Cotignola
Country
Italy
Facility Name
Azienda Ospedaliera Carlo Poma
City
Mantova
Country
Italy
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Maastricht University Hospital
City
Maastricht
Country
Netherlands
Facility Name
Complejo Hospitalario Universitario De A Coruña
City
A Coruna
ZIP/Postal Code
15009
Country
Spain
Facility Name
Hospital University Germans Trias I Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen De La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Victoria Hospital
City
Blackpool
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30497085
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.
Results Reference
background
PubMed Identifier
33478837
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.
Results Reference
result
PubMed Identifier
35290444
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.
Results Reference
derived
PubMed Identifier
34118150
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.
Results Reference
derived
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Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
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