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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02673697
Ethics application status
Date submitted
21/01/2016
Date registered
4/02/2016
Date last updated
24/10/2018

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
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

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
Freedom from 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.
Timepoint [1] 0 0
1 year post-operatively
Secondary outcome [1] 0 0
Surgical times - Cross clamp time during index procedure
Cardiopulmonary bypass time during index procedure
Timepoint [1] 0 0
Intra-operative
Secondary outcome [2] 0 0
Normalized Consumption Index - Normalized Consumption Index including resource consumption items such as (but not limited to):
Operative room time,
Duration of ICU and total hospital stay
Incidence of specific serious adverse events as defined in Appendix 3
Blood transfusion
Timepoint [2] 0 0
Hospital Discharge (average 10 days)
Secondary outcome [3] 0 0
Reduced Normalized Consumption Index - Reduced Normalized Consumption Index, including resource consumption items such as (but not limited to):
Operative room time,
Duration of ICU and total hospital stay
Incidence of specific serious adverse events as defined in Appendix 3
Blood transfusion
Timepoint [3] 0 0
Hospital Discharge (average 10 days)
Secondary outcome [4] 0 0
Quality of life questionnaire - Questionnaire for quality of life (EQ5D)
Timepoint [4] 0 0
At 1 month and 1 year post surgery
Secondary outcome [5] 0 0
Intraprocedural and periprocedural serious adverse events regardless of relationship with the device
Timepoint [5] 0 0
72 hours post surgery
Secondary outcome [6] 0 0
All valve and procedure relevant serious adverse events as specified in Valve Academic Research Consortium-2 (VARC-2) guidelines - Early safety at 30 days
Clinical efficacy after 30 days
Time related valve safety: [Structural Valve Deterioration (SVD), endocarditis, Thrombosis, Thromboembolic events (excluding stroke), and bleeding] annually up to 5 years
Timepoint [6] 0 0
At 30 days and annually up to 5 years post surgery
Secondary outcome [7] 0 0
Serious device related adverse events
Timepoint [7] 0 0
Up to 5 years post surgery
Secondary outcome [8] 0 0
Freedom from MACCE
Timepoint [8] 0 0
At 2, 3, 4 and 5 years post surgery
Secondary outcome [9] 0 0
Rate of Pacemaker implantation - The rate of pacemaker implantation during the first year post surgery will be analyzed
Timepoint [9] 0 0
Up to 1 year post surgery
Secondary outcome [10] 0 0
Echocardiographic endpoints (site-reported data) - Performance of the valve in terms of hemodynamic behavior
Timepoint [10] 0 0
Preoperatively, at hospital discharge (average 10 days), between 1-3 month, 1 year, 3 year and 5 years post surgery
Secondary outcome [11] 0 0
Echocardiographic endpoints in a reduced cohort of patients assessed by core lab - Performance of the valve in terms of hemodynamic behavior.
Timepoint [11] 0 0
Preoperatively, at hospital discharge (average 10 days), between 1-3 month, 1 year, 3 year and 5 years post surgery

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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourn - Parkville VIC
Recruitment postcode(s) [1] 0 0
3050 - Parkville VIC
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Antwerp
Country [4] 0 0
Belgium
State/province [4] 0 0
Bruxelles
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
France
State/province [9] 0 0
Angers
Country [10] 0 0
France
State/province [10] 0 0
Besançon
Country [11] 0 0
France
State/province [11] 0 0
Bois Bernard
Country [12] 0 0
France
State/province [12] 0 0
Montpellier
Country [13] 0 0
France
State/province [13] 0 0
Nancy
Country [14] 0 0
France
State/province [14] 0 0
Poitiers
Country [15] 0 0
Germany
State/province [15] 0 0
Bad Krozingen
Country [16] 0 0
Germany
State/province [16] 0 0
Bad Neustadt
Country [17] 0 0
Germany
State/province [17] 0 0
Dresden
Country [18] 0 0
Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Germany
State/province [19] 0 0
Hannover
Country [20] 0 0
Germany
State/province [20] 0 0
Nürnberg
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Israel
State/province [22] 0 0
Jerusalem
Country [23] 0 0
Israel
State/province [23] 0 0
Tel Aviv
Country [24] 0 0
Italy
State/province [24] 0 0
BS
Country [25] 0 0
Italy
State/province [25] 0 0
CT
Country [26] 0 0
Italy
State/province [26] 0 0
MI
Country [27] 0 0
Italy
State/province [27] 0 0
MS
Country [28] 0 0
Italy
State/province [28] 0 0
Brescia
Country [29] 0 0
Italy
State/province [29] 0 0
Chieti
Country [30] 0 0
Italy
State/province [30] 0 0
Mantova
Country [31] 0 0
Netherlands
State/province [31] 0 0
Eindhoven
Country [32] 0 0
Netherlands
State/province [32] 0 0
Maastricht
Country [33] 0 0
Romania
State/province [33] 0 0
Sibiu
Country [34] 0 0
Spain
State/province [34] 0 0
A Coruna
Country [35] 0 0
Spain
State/province [35] 0 0
Badalona
Country [36] 0 0
Spain
State/province [36] 0 0
Murcia
Country [37] 0 0
Turkey
State/province [37] 0 0
Ankara
Country [38] 0 0
Turkey
State/province [38] 0 0
Istanbul
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Blackpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
LivaNova
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.

A minimum of 1234 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/show/NCT02673697
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

Summary results
Other publications