Prospective randomised trial of stented versus stentless bioprosthesis for aortic valve replacement (AVR)
Completed
- Conditions
- Aortic valve replacementCirculatory System
- Registration Number
- ISRCTN56511757
- Lead Sponsor
- Papworth Hospital NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post-operative pressure gradient across the prosthetic valve and effective valve orifice area.
- Secondary Outcome Measures
Name Time Method o secondary outcome measures