Prospective randomised trial of stented versus stentless bioprosthesis for aortic valve replacement (AVR)
ISRCTN | ISRCTN56511757 |
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DOI | https://doi.org/10.1186/ISRCTN56511757 |
Secondary identifying numbers | P00715 |
- Submission date
- 16/05/2005
- Registration date
- 08/07/2005
- Last edited
- 04/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Steven Tsui
Scientific
Scientific
Surgical Unit
Papworth Hospital NHS Trust
Papworth Everard
CB3 8RE
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | To find out which prosthetic valves represent the better option for patients requiring AVR. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Aortic valve replacement |
Intervention | Prima Plus (Edwards Lifesciences) stentless bioprosthesis or the Carpentier-Edwards Perimount stented bioprosthesis (Edwards Lifesciences). |
Intervention type | Other |
Primary outcome measure | Post-operative pressure gradient across the prosthetic valve and effective valve orifice area. |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/03/2001 |
Completion date | 05/07/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 240 |
Key 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 |
Key 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 |
Date of first enrolment | 01/03/2001 |
Date of final enrolment | 05/07/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Surgical Unit
Papworth Everard
CB3 8RE
United Kingdom
CB3 8RE
United Kingdom
Sponsor information
Papworth Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Surgical Unit
Papworth Everard
CB3 8RE
England
United Kingdom
https://ror.org/01qbebb31 |
Funders
Funder type
Industry
Edwards LifeSciences Ltd (UK) - Industrial grant
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 01/06/2007 | Yes | No |