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ISRCTN
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ISRCTN56511757
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ClinicalTrials.gov identifier
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Public title
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Prospective randomised trial of stented versus stentless bioprosthesis for aortic valve replacement (AVR)
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Scientific title
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Acronym
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N/A
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Serial number at source
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P00715
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Study hypothesis
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To find out which prosthetic valves represent the better option for patients requiring AVR.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Aortic valve replacement
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Participants - inclusion criteria
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Inclusion criteria:
1. Patients who require elective AVR with a tissue valve for symptomatic aortic valve stenosis (peak valve gradient equal to or greater than 50 mmHg as measured by echocardiography), with or without concomitant artery bypass grafting
2. Patients = 65 years of age at the time of surgery
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Participants - exclusion criteria
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1. Patients who are already enrolled in another major cardiovascular trial
2. AVR performed primarily for aortic valve regurgitation
3. Active aortic valve infection
4. Active malignant disease
5. Renal failure requiring dialysis
6. Any previous cardiac surgery
7. The need for additional cardiac procedures other than coronary artery bypass grafting
8. Emergency operations
9. Patients unable to give informed consent
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Anticipated start date
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01/03/2001
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Anticipated end date
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05/07/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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240
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Interventions
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Prima Plus (Edwards Lifesciences) stentless bioprosthesis or the Carpentier-Edwards Perimount stented bioprosthesis (Edwards Lifesciences).
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Primary outcome measure(s)
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Post-operative pressure gradient across the prosthetic valve and effective valve orifice area.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Edwards LifeSciences Ltd (UK) - Industrial grant
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17532416
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Contact name
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Mr
Steven
Tsui
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Address
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Surgical Unit
Papworth Hospital NHS Trust
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City/town
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Papworth Everard
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Sponsor
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Papworth Hospital NHS Trust (UK)
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Address
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Surgical Unit
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City/town
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Papworth Everard
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Date applied
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16/05/2005
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Last edited
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04/10/2007
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Date ISRCTN assigned
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08/07/2005
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