Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P00715
Study information
Scientific title
Acronym
Study hypothesis
To find out which prosthetic valves represent the better option for patients requiring AVR.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Aortic valve replacement
Intervention
Prima Plus (Edwards Lifesciences) stentless bioprosthesis or the Carpentier-Edwards Perimount stented bioprosthesis (Edwards Lifesciences).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Post-operative pressure gradient across the prosthetic valve and effective valve orifice area.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2001
Overall trial end date
05/07/2005
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
240
Participant exclusion criteria
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
Recruitment start date
01/03/2001
Recruitment end date
05/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Surgical Unit
Papworth Everard
CB3 8RE
United Kingdom
Funders
Funder type
Industry
Funder name
Edwards LifeSciences Ltd (UK) - Industrial grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17532416
Publication citations
-
Results
Ali A, Halstead JC, Cafferty F, Sharples L, Rose F, Lee E, Rusk R, Dunning J, Argano V, Tsui S, Early clinical and hemodynamic outcomes after stented and stentless aortic valve replacement: results from a randomized controlled trial., Ann. Thorac. Surg., 2007, 83, 6, 2162-2168, doi: 10.1016/j.athoracsur.2007.01.021.