ACTRN12613000306718Not yet recruiting未知
Assessing the safety and efficacy of the Perceval S Sutureless Valve implantation compared to ISO 5840 objective performance criteria in Aortic Valve Replacement patients
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- The Prince Charles Hospital
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 65 Years to 100 Years (—)
- Sex
- All
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.
Investigators
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