Aortic valve replacement Circulatory System Aortic valve replacement
Conditions
Interventions
Prima Plus (Edwards Lifesciences) stentless bioprosthesis or the Carpentier-Edwards Perimount stented bioprosthesis (Edwards Lifesciences).
Sponsors
Papworth Hospital NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative pressure gradient across the prosthetic valve and effective valve orifice area. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed