Is less more? A sutureless valve study. Assessing the safety and efficacy of the Perceval S Sutureless Valve implantation

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613000306718
• Date of registration: 20/03/2013
• Prospective Registration: Yes
• Primary sponsor: The Prince Charles Hospital
• 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
• Date of first enrolment: 01/05/2013
• Target sample size: 150
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613000306718.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Peter Tesar

• Name: Dr Peter Tesar

Key inclusion & exclusion criteria

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)

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.


Age minimum: 65 Years
Age maximum: 100 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Other cardiovascular diseases

Surgery - Other surgery

Aortic Valve Replacement surgery patients;
Aortic Valve Replacement surgery patients

Intervention(s)

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)

Primary Outcome(s)

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.
[Echocardiogram and Medical assessment recorded at;
5 days 6 weeks, 6, 12 months and 5 years postoperative.
]

length of hospital stay[Hospital length of stay recorded by input of admission and discharge dates from patient medical records. ]

Evaluating mortality/morbidity
[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. ]

Secondary Outcome(s)

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.
[Recorded during preoperative medical assessment.
6 weeks, 6 and 12 months postoperatively. ]

Demonstration of efficacy:
Improved haemodynamic performance in echocardiogram data over postoperative follow-up period.
[preoperative echocardiogram assessment.
5 days, 6, 12 months and 5 years postoperative echocardiogram assessment.
]

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. [Total surgical time will be extracted from Theatre Database and recorded in research participant data file. ]

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.[Survey to be attended by participant preoperatively, 6 weeks, 6 months and 12 months postoperatively. ]

Secondary ID(s)

nil

Source(s) of Monetary Support

The Prince Charles Hospital

Ethics review

Status: Approved
Approval date:
Contact:

The Prince Charles Hospital, HREC