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Trial registered on ANZCTR


Registration number
ACTRN12613000306718
Ethics application status
Approved
Date submitted
8/03/2013
Date registered
20/03/2013
Date last updated
20/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Is less more? A sutureless valve study. Assessing the safety and efficacy of the Perceval S Sutureless Valve implantation
Scientific title
Assessing the safety and efficacy of the Perceval S Sutureless Valve implantation compared to ISO 5840 objective performance criteria in Aortic Valve Replacement patients
Secondary ID [1] 281957 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Replacement surgery patients 288375 0
Condition category
Condition code
Surgery 288719 288719 0 0
Other surgery
Cardiovascular 288998 288998 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Perceval S Sutureless Valve device implantation.

The Perceval S Sutureless Valve (PSSV) is a prosthetic heart valve that can be implanted without sutures using a conventional surgical technique that allows removal of the diseased native valve. It is produced with the same material as a standard tissue valve and is mounted on an expandable frame that seals into the heart with similar technology used in Trans-catheter aortic valve implantation (TAVI), but is specifically designed for surgical implantation.

The functional component of the PSSV is comprised of bovine pericardium fixed in a nitinol cage. The cage is characterised by two ring segments on the proximal and distal end, with a number of supportive elements to allow the valve to anchor to the aortic root. The cage is collapsible for implantation.

Implantation time for a PSSV is significantly shorter than standard AVR surgical implantation time as complete removal of calcified tissue is not required, which also reduces the chance of creating defects in the aorta. Myocardial ischemic time is reduced due to shortened aortic cross clamp time.

Individual surgery times may vary depending on the attending surgeon and additional procedures required (eg CABG)
Intervention code [1] 286524 0
Treatment: Devices
Intervention code [2] 286758 0
Treatment: Surgery
Comparator / control treatment
International Stardard ISO 5840: Cardiovascular implants - cardiac valve prosthesis. (4th edition 2005)

This International Standard is applicable to both newly developed and modified heart valve substitutes. It outlines an approach for qualifying the design and manufacture of a heart valve substitute.

Clinical investigations on new heart valve designs must be carried out in accordance with this Standard, including:
number of patients, duration of study, clinical data requirements, clinical investigation report.

Safety and efficacy can be assessed by comparing all complications to objective performance criteria (OPC) published in the ISO guidelines. The OPC are the acceptable rates of valve-related complications and may be used without further justification.

Control group
Uncontrolled

Outcomes
Primary outcome [1] 288862 0
Demonstration of safety of device:
Evaluating post-operative complications

Examples of expected complication:

Structural Valve Deterioration;
Dysfunction or deterioration involving the operated valve as determined by reoperation, autopsy, or clinical investigation (exclusive of infection or thrombosis).
Changes intrinsic to the valve, such as wear, fracture, poppet escape, calcification, leaflet tear, stent creep, suture line disruption of components of a prosthetic valve, new chordal rupture, leaflet disruption, or leaflet retraction of a repaired valve.

Nonstructural Dysfunction;
Any abnormality not intrinsic to the valve itself that results in stenosis or regurgitation of the operated valve or hemolysis.
Problems that do not directly involve valve components yet result in dysfunction of an operated valve, such as: entrapment by pannus, tissue, or suture; paravalvular leak; inappropriate sizing or positioning; residual leak or obstruction after valve implantation or repair; and clinically important intravascular haemolytic anaemia.
Also includes development of aortic or pulmonic regurgitation as a result of technical errors, dilatation of the valve annulus; new onset of coronary ischaemia form coronary ostial obstruction or paravalular aortic regurgitation.
Timepoint [1] 288862 0
Echocardiogram and Medical assessment recorded at;
5 days 6 weeks, 6, 12 months and 5 years postoperative.
Primary outcome [2] 289066 0
Evaluating mortality/morbidity
Timepoint [2] 289066 0
Patient survival status recorded at 6 weeks, 6, 12 and 24 months and 5 years postoperative, from outpatient appointment attendence and/or telephone contact with participant.
Primary outcome [3] 289067 0
length of hospital stay
Timepoint [3] 289067 0
Hospital length of stay recorded by input of admission and discharge dates from patient medical records.
Secondary outcome [1] 301182 0
Demonstration of efficacy:
Improved haemodynamic performance in echocardiogram data over postoperative follow-up period.
Timepoint [1] 301182 0
preoperative echocardiogram assessment.
5 days, 6, 12 months and 5 years postoperative echocardiogram assessment.
Secondary outcome [2] 301665 0
Improved SF-36 scores post-operatively

The SF-36v2 "Registered Trademark" Health Survey (SF-36v2) is a multipurpose,
short-form health survey with 36 questions
that yields an eight-scale profi le of functional health
and well-being, as well as two psychometrically based
physical and mental health summary measures and a
preference-based health utility index.
Timepoint [2] 301665 0
Survey to be attended by participant preoperatively, 6 weeks, 6 months and 12 months postoperatively.
Secondary outcome [3] 301666 0
Improved NYHA classification post-operatively

The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain.
Timepoint [3] 301666 0
Recorded during preoperative medical assessment.
6 weeks, 6 and 12 months postoperatively.
Secondary outcome [4] 301667 0
Reduced operation times

Implantation time for a PSSV is significantly shorter than standard AVR surgical implantation time as complete removal of calcified tissue is not required. Myocardial ischemic time is reduced due to shortened aortic cross clamp time.

It is therefore expected that an overall reduction in surgery times will be observed.
Timepoint [4] 301667 0
Total surgical time will be extracted from Theatre Database and recorded in research participant data file.

Eligibility
Key inclusion criteria
Key Inclusion Criteria
=>65 years
Acquired calcific/degenerative (trileaflet) Aortic Valve
Isolated Elective Aortic Valve Replacement recipient
NYHA class III, IV or V
Nil to minimal Aortic Regurgitation on preoperative Echo
Agree to attend additional follow up appointments (including possible phone contact)
Minimum age
65 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key Exclusion Criteria
< 65 years
Recent myocardial infarction (<90 days)
Active endocarditis or myocarditis
Aortic Annulus < 19mm or >25mm
Bicuspid Aortic Valve
Ascending Aorta dissection
Aneurysmal Aorta dilation >4cm
Previous valve prosthesis or annuloplasty ring implantation
Patients requiring multiple valve replacement / repair
Known hypersensitivity to nickel alloys
Patients with chronic renal impairment or calcium metabolism disorders
Patients receiving chronic drug treatment with preparation containing calcium
Patients with acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilised 30 days prior to planned valve implant surgery
Patients with anatomical characteristics outside the specifications given in Investigators brochure.
Patients unable to read write and speak in the English language.
Patients with cognitive impairment.
Pregnant women.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be screened through physician and surgeon assessment for study candidate suitability and will be invited to participate by their cardiac surgeon.
Inclusion/Exclusion criteria will be complied with.

Single treatment arm. Non randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
QLD
Recruitment hospital [1] 575 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 6321 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 286742 0
Hospital
Name [1] 286742 0
The Prince Charles Hospital
Address [1] 286742 0
Rode Road, Chermside. Qld 4032
Country [1] 286742 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
Rode Road, Chermside. QLD 4032
Country
Australia
Secondary sponsor category [1] 285525 0
None
Name [1] 285525 0
Address [1] 285525 0
Country [1] 285525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288805 0
The Prince Charles Hospital, HREC
Ethics committee address [1] 288805 0
Rode Road, Chermside. QLD 4032
Ethics committee country [1] 288805 0
Australia
Date submitted for ethics approval [1] 288805 0
Approval date [1] 288805 0
23/01/2013
Ethics approval number [1] 288805 0
HREC/12/QPCH/294

Summary
Brief summary
A prospective, single arm, single centre, open label, clinical trial to evaluate the safety and efficacy of the Perceval S Sutureless aortic valve prosthesis. More specifically to assess:
Functional performance of the valve through echocardiograms pre-operatively, intra-operatively and 5 days, 6, 12 and 24 months and 5 years post-operatively
Quality of life with the SF36 pre-operatively, 6 weeks and 6 and 12 months post-operatively
Mortality
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37858 0
Dr Peter Tesar
Address 37858 0
Cardiothoracic Surgery Department
The Prince Charles Hospital
Rode Rd, Chermside. QLD 4032
Country 37858 0
Australia
Phone 37858 0
+61 7 3139 5365
Fax 37858 0
Email 37858 0
tesarp@health.qld.gov.au
Contact person for public queries
Name 37859 0
Dr Peter Tesar
Address 37859 0
Cardiothoracic Surgery Department
The Prince Charles Hospital
Rode Rd, Chermside. QLD 4032
Country 37859 0
Australia
Phone 37859 0
+61 7 3139 5365
Fax 37859 0
Email 37859 0
tesarp@health.qld.gov.au
Contact person for scientific queries
Name 37860 0
Dr Peter Tesar
Address 37860 0
Cardiothoracic Surgery Department
The Prince Charles Hospital
Rode Rd, Chermside. QLD 4032
Country 37860 0
Australia
Phone 37860 0
+61 7 3139 5365
Fax 37860 0
Email 37860 0
tesarp@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results