Status:
COMPLETED
Medtronic's MOSAIC Bioprosthesis Versus Baxter Carpentier-Edwards SAV Porcine Valve
Lead Sponsor:
University Hospital Plymouth NHS Trust
Conditions:
Cardiac Valve Replacement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study compares the clinical performance of the Mosaic valve with that of the Baxter valve (Carpentier-Edwards) which is widely used throughout the UK and is considered to be the "bench mark". Spe...
Detailed Description
The bioprostheses (xenografts) to be used in this study are third generation valves derived from porcine aortic valves. The chief advantage over mechanical prostheses is that they do not require lifel...
Eligibility Criteria
Inclusion
- Patients who require isolated or combined aortic or mitral valve replacement with or without coronary artery bypass grafting
- Patients requesting anticoagulation-free therapy
- Patients who are able to provide informed consent
Exclusion
- Concomitant procedures other than coronary artery bypass grafting
- Presence of illness other than valve disease that would substantially increase the likelihood of death within one year
- Patients unlikely to be available for long term follow-up activities
- Patients indicated for receiving a mechanical prosthesis
- Patients refusing or not able to provide informed consent
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2016
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT03346044
Start Date
January 1 2001
End Date
January 12 2016
Last Update
November 17 2017
Active Locations (1)
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1
Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom, PL6 8BX