None listed
Conditions
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
Interventions
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 im
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)
Sponsors
The Prince Charles Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Healthy volunteers
No
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.
Outcome results
None listed