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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02673697
Registration number
NCT02673697
Ethics application status
Date submitted
21/01/2016
Date registered
4/02/2016
Date last updated
27/07/2022
Titles & IDs
Public title
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
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Scientific title
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease
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Secondary ID [1]
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TPS003
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Universal Trial Number (UTN)
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Trial acronym
PERSIST-AVR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Disease
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Aortic Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Perceval valve
Treatment: Devices - other stented biological valve
Experimental: Perceval - 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.
Active Comparator: other Stented biological valves - 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.
Treatment: Devices: Perceval valve
Sutureless Aortic Biological Valve
Treatment: Devices: other stented biological valve
Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)
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Assessment method [1]
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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.
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Timepoint [1]
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1 year post-operatively
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Secondary outcome [1]
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Surgical Times
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Assessment method [1]
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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
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Timepoint [1]
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Intra-operative
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/07/2020
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Sample size
Target
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Accrual to date
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Final
914
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Indiana
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Maine
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Graz
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Murcia
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Blackpool
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Corcym S.r.l
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02673697
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Trial related presentations / 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.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Theodor Fischlein, MD
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Address
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Klinikum Nurnberg, Nurnberg, Germany
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02673697
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