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

Not Applicable

• Conditions: Aortic Valve Replacement surgery patients; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000306718
• Lead Sponsor: The Prince Charles Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified