Aortic Valve DiseasePERSIST-AVRNCT02673697
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
A study testing Perceval valve and other stented biological valve in people with Aortic Valve Disease and Aortic Stenosis, run by Corcym S.r.l at 47 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Stenosis
- What is being tested?
- Perceval valve and other stented biological valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 914 participants
- Where
- 47 sitesin 12 countries
- Study dates
- 22 Mar 2016to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
47 sites in 12 countries.
47 sites in 12 countries
Italy8 sites
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, BS, 25124
Spedali Civili
Brescia
Maria Cecilia Hospital
Cotignola
Azienda Ospedaliera Carlo Poma
Mantua
Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
Massa, MS, 54100
Ospedale San Raffaele
Milan, MI, 20132
lstituto Clinico Sant'Ambrogio e San Siro
Milan, MI, 20149
Centro Cuore Morgagni Pedara
Pedara, CT, 95030
France7 sites
CHU Angers
Angers, 49000
C.H.U. de Besançon
Besançon
Hôpital privé de Bois Bernard
Bois-Bernard
Chru De Lille
Lille
CHU Arnaud de Villeneuve
Montpellier, 34295
C.H.U. de Nancy
Nancy
CHU de Poitiers
Poitiers
Germany7 sites
Herzzentrum Bad Krozingen
Bad Krozingen
Herz- und Gefäß-Klinik
Bad Neustadt an der Saale
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, 1307
ASKLEPIOS Klinikum Harburg
Hamburg, D- 21075
University Heart Center Hamburg
Hamburg, D-20246
Medizinische Hochschule
Hanover
Klinikum Nürnberg
Nuremberg
United States5 sites
Heart and Vascular Institute, Cleveland Clinic
Cleveland, Ohio, 44195
Houston Methodist Research Institute, Houston Methodist Hospital
Houston, Texas, 77030
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46260
Maine Medical Center
Portland, Maine, 04102
Valley Health System
Winchester, Virginia, 22601
Austria4 sites
Klinische Abteilung fuer Herzchirurgie
Graz
Medical University of Innsbruck
Innsbruck
Herzzentrum Hietzing
Vienna
Medical University of Vienna
Vienna
Canada4 sites
University of Alberta
Edmonton, Alberta, 2H234
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, G1V 4G5
Belgium3 sites
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
Cliniques Univ. Saint-Luc
Brussels
Universitair Ziekenhuis
Leuven
Spain3 sites
Complejo Hospitalario Universitario De A Coruña
A Coruña, 15009
Hospital University Germans Trias I Pujol
Badalona
Hospital Clinico Universitario Virgen De La Arrixaca
Murcia, 30120
Israel2 sites
Shaare Zedek Medical Center
Jerusalem, 9103102
Sheba medical Center
Tel Aviv
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven
Maastricht University Hospital
Maastricht
About this study
Official title: Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease
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.
Read the 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
- Being tested
- Perceval valve, other stented biological valve
- Keywords
- Sutureless valve
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceval valveDevice
Sutureless Aortic Biological Valve
other stented biological valveDevice
Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: other stented biological valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post-operatively
Secondary outcomes (1)
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
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start22 Mar 2016
- Primary completion17 Jan 2020
- Study completion31 Jul 2020
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcym S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theodor Fischlein, MD, Principal investigator, Klinikum Nurnberg, Nurnberg, GermanyRoberto Lorusso, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673697
- Sponsor's protocol ID
- TPS003
- Acronym
- PERSIST-AVR
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2016
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30497085Fischlein 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.
PubMed 33478837Lorusso 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.
PubMed 35290444Lorusso 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.
PubMed 34118150
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT02673697
- Acronym / sponsor ID
- PERSIST-AVR / TPS003
- Conditions
- Aortic Valve Disease, Aortic Stenosis
- Keywords
- Sutureless valve
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 27 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perceval | Experimental | Device: Perceval valveThe 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. |
| other Stented biological valves | Active comparator | Device: other stented biological valveThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceval valveSutureless Aortic Biological Valve | Device | Perceval |
| other stented biological valveAny biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor) | Device | other Stented biological valves |
Primary outcome
Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 1 year post-operatively
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 secondary outcome
Surgical Times
Time frame: Intra-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30497085Lorusso 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 publication: PubMed 33478837Fischlein 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.
- Derived from this study: PubMed 35290444Lorusso 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.
- Derived from this study: PubMed 34118150Lorusso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodor Fischlein, MD principal investigator
Klinikum Nurnberg, Nurnberg, Germany
Roberto Lorusso, MD, PhD principal investigator
Maastricht University Medical Center
47 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceval valve and other stented biological valve in people with Aortic Valve Disease and Aortic Stenosis, run by Corcym S.r.l at 47 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Italy, France, Germany, United States, Austria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE) (time frame: 1 year post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02673697, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.