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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02673697




Registration number
NCT02673697
Ethics application status
Date submitted
21/01/2016
Date registered
4/02/2016

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
Cancer 0 0 0 0
Thyroid
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Head and neck
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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
Secondary outcome [2] 0 0
Number of participants with acute Graft-versus-host disease (aGvHD) according to the Glucksberg scale and Seattle criteria
Timepoint [2] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [3] 0 0
Number of participants with chronic Graft-versus-host disease (cGvHD) according to the Glucksberg scale and Seattle criteria
Timepoint [3] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [4] 0 0
Number of participants with VOD/SOS according to the Seattle criteria
Timepoint [4] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [5] 0 0
Number of participants with Neutrophil recovery as a measure of Safety and Tolerability
Timepoint [5] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [6] 0 0
Number of participants with Platelet recovery as a measure of Safety and Tolerability
Timepoint [6] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [7] 0 0
Number of participants with Primary graft failure or rejection as a measure of Safety and Tolerability
Timepoint [7] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [8] 0 0
Transplant related mortality (TRM)
Timepoint [8] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [9] 0 0
Event free survival (EFS)
Timepoint [9] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [10] 0 0
Overall survival (OS)
Timepoint [10] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [11] 0 0
Cumulative incidence of relapse
Timepoint [11] 0 0
18 months after inclusion of first patient, afterwards, annually up to 10 years
Secondary outcome [12] 0 0
change in dysphagia across different patient treatments
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
change in dysphagia across different patient treatments
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
change in dysphagia across different patient treatments
Timepoint [14] 0 0
24 months
Secondary outcome [15] 0 0
change in dysphagia across different patient treatments
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
change in dysphagia across different patient treatments
Timepoint [16] 0 0
24 months
Secondary outcome [17] 0 0
change in rate of secondary treatment side effect
Timepoint [17] 0 0
24 months
Secondary outcome [18] 0 0
change in rate of secondary treatment side effect
Timepoint [18] 0 0
24 months
Secondary outcome [19] 0 0
change in rate of secondary treatment side effect
Timepoint [19] 0 0
24 months

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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
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)
NSW
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- St Leonards
Recruitment hospital [3] 0 0
University of New South Wales - St. George Hospital - Sydney
Recruitment hospital [4] 0 0
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute - Darlinghurst
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
- St Leonards
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
NSW 2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Austria
State/province [7] 0 0
Graz
Country [8] 0 0
Austria
State/province [8] 0 0
Innsbruck
Country [9] 0 0
Austria
State/province [9] 0 0
Vienna
Country [10] 0 0
Austria
State/province [10] 0 0
Wien
Country [11] 0 0
Belgium
State/province [11] 0 0
Antwerp
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Santiago
Country [18] 0 0
France
State/province [18] 0 0
Angers
Country [19] 0 0
France
State/province [19] 0 0
Besançon
Country [20] 0 0
France
State/province [20] 0 0
Bois Bernard
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Montpellier
Country [23] 0 0
France
State/province [23] 0 0
Nancy
Country [24] 0 0
France
State/province [24] 0 0
Poitiers
Country [25] 0 0
Germany
State/province [25] 0 0
Bad Krozingen
Country [26] 0 0
Germany
State/province [26] 0 0
Bad Neustadt An Der Saale
Country [27] 0 0
Germany
State/province [27] 0 0
Dresden
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Hannover
Country [30] 0 0
Germany
State/province [30] 0 0
Nürnberg
Country [31] 0 0
Israel
State/province [31] 0 0
Jerusalem
Country [32] 0 0
Israel
State/province [32] 0 0
Tel Aviv
Country [33] 0 0
Italy
State/province [33] 0 0
BS
Country [34] 0 0
Italy
State/province [34] 0 0
CT
Country [35] 0 0
Italy
State/province [35] 0 0
MI
Country [36] 0 0
Italy
State/province [36] 0 0
MS
Country [37] 0 0
Italy
State/province [37] 0 0
Brescia
Country [38] 0 0
Italy
State/province [38] 0 0
Cotignola
Country [39] 0 0
Italy
State/province [39] 0 0
Mantova
Country [40] 0 0
Netherlands
State/province [40] 0 0
Eindhoven
Country [41] 0 0
Netherlands
State/province [41] 0 0
Maastricht
Country [42] 0 0
Spain
State/province [42] 0 0
A Coruna
Country [43] 0 0
Spain
State/province [43] 0 0
Badalona
Country [44] 0 0
Spain
State/province [44] 0 0
Murcia
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Blackpool
Country [46] 0 0
United States of America
State/province [46] 0 0
California
Country [47] 0 0
United States of America
State/province [47] 0 0
District of Columbia
Country [48] 0 0
United States of America
State/province [48] 0 0
Florida
Country [49] 0 0
United States of America
State/province [49] 0 0
Massachusetts
Country [50] 0 0
United States of America
State/province [50] 0 0
Minnesota
Country [51] 0 0
United States of America
State/province [51] 0 0
New York
Country [52] 0 0
United States of America
State/province [52] 0 0
North Carolina
Country [53] 0 0
United States of America
State/province [53] 0 0
Oregon
Country [54] 0 0
United States of America
State/province [54] 0 0
Pennsylvania
Country [55] 0 0
France
State/province [55] 0 0
Calvados
Country [56] 0 0
France
State/province [56] 0 0
Gironde
Country [57] 0 0
France
State/province [57] 0 0
Maine Et Loire
Country [58] 0 0
France
State/province [58] 0 0
Rhone
Country [59] 0 0
France
State/province [59] 0 0
Val De Marne
Country [60] 0 0
Italy
State/province [60] 0 0
Milano
Country [61] 0 0
Italy
State/province [61] 0 0
Pisa
Country [62] 0 0
Italy
State/province [62] 0 0
Roma
Country [63] 0 0
Italy
State/province [63] 0 0
Siena
Country [64] 0 0
United Kingdom
State/province [64] 0 0
South Glamorgan
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Strathclyde
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Surrey
Country [67] 0 0
Switzerland
State/province [67] 0 0
Cansearch Laboratory
Country [68] 0 0
Switzerland
State/province [68] 0 0
Basel
Country [69] 0 0
Switzerland
State/province [69] 0 0
Geneva
Country [70] 0 0
Switzerland
State/province [70] 0 0
Zurich
Country [71] 0 0
United States of America
State/province [71] 0 0
Colorado
Country [72] 0 0
United States of America
State/province [72] 0 0
Missouri
Country [73] 0 0
United States of America
State/province [73] 0 0
Washington
Country [74] 0 0
China
State/province [74] 0 0
Hong Kong
Country [75] 0 0
United States of America
State/province [75] 0 0
Utah
Country [76] 0 0
France
State/province [76] 0 0
Paris
Country [77] 0 0
Italy
State/province [77] 0 0
Bologna
Country [78] 0 0
Spain
State/province [78] 0 0
La Coruna

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Corcym S.r.l
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ALL SCTped Forum
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT02673697