Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease
Secondary ID [1] 0 0
TPS003
Universal Trial Number (UTN)
Trial acronym
PERSIST-AVR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Disease 0 0
Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants With Freedom From Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Timepoint [1] 0 0
1 year post-operatively
Secondary outcome [1] 0 0
Surgical Times
Timepoint [1] 0 0
Intra-operative

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2020
Sample size
Target
Accrual to date
Final
914
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Maine
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Austria
State/province [6] 0 0
Graz
Country [7] 0 0
Austria
State/province [7] 0 0
Innsbruck
Country [8] 0 0
Austria
State/province [8] 0 0
Vienna
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerp
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Chile
State/province [16] 0 0
Santiago
Country [17] 0 0
France
State/province [17] 0 0
Angers
Country [18] 0 0
France
State/province [18] 0 0
Besançon
Country [19] 0 0
France
State/province [19] 0 0
Bois Bernard
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
France
State/province [21] 0 0
Montpellier
Country [22] 0 0
France
State/province [22] 0 0
Nancy
Country [23] 0 0
France
State/province [23] 0 0
Poitiers
Country [24] 0 0
Germany
State/province [24] 0 0
Bad Krozingen
Country [25] 0 0
Germany
State/province [25] 0 0
Bad Neustadt An Der Saale
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Hannover
Country [29] 0 0
Germany
State/province [29] 0 0
Nürnberg
Country [30] 0 0
Israel
State/province [30] 0 0
Jerusalem
Country [31] 0 0
Israel
State/province [31] 0 0
Tel Aviv
Country [32] 0 0
Italy
State/province [32] 0 0
BS
Country [33] 0 0
Italy
State/province [33] 0 0
CT
Country [34] 0 0
Italy
State/province [34] 0 0
MI
Country [35] 0 0
Italy
State/province [35] 0 0
MS
Country [36] 0 0
Italy
State/province [36] 0 0
Brescia
Country [37] 0 0
Italy
State/province [37] 0 0
Cotignola
Country [38] 0 0
Italy
State/province [38] 0 0
Mantova
Country [39] 0 0
Netherlands
State/province [39] 0 0
Eindhoven
Country [40] 0 0
Netherlands
State/province [40] 0 0
Maastricht
Country [41] 0 0
Spain
State/province [41] 0 0
A Coruna
Country [42] 0 0
Spain
State/province [42] 0 0
Badalona
Country [43] 0 0
Spain
State/province [43] 0 0
Murcia
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Blackpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Corcym S.r.l
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02673697
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.
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

Contacts
Principal investigator
Name 0 0
Theodor Fischlein, MD
Address 0 0
Klinikum Nurnberg, Nurnberg, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02673697