Comparative Analysis of Stented Biological Prosthesis Versus Aortic Allograft in Patients With Degenerative Aortic Valve Disease
- Conditions
- Bioprosthesis FailureAllograft
- Registration Number
- NCT07210541
- Lead Sponsor
- Chelyabinsk Regional Clinical Hospital
- Brief Summary
The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft.
- Detailed Description
Early safety included morbidity, mortality rate, freedom from any valve related complications Clinical efficacy included mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication Time-to-event analysis included freedom from all-cause and cardio-vascular mortality, freedom from stroke, major bleeding, endocarditis, structural valve deterioration and reoperation
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- Patients with degenerative aortic valve disease not emendable for aortic valve repair
- Elective surgery
- Left ventricle ejection fraction less than 40%
- Redo surgery
- Indication for concomitant mitral valve replacement
- Aortic valve/root endocarditis
- Severe COPD
- Dialysis patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 30 days Early cardio-vascular mortality
- Secondary Outcome Measures
Name Time Method Mortality 2 years All-cause mortality
Structural valve deterioration 2 years New onset aortic regurgitation (vc \>0,6) or escalated mean pressure gradient over 20 mmHg.
Stroke 2 years Ischemic stroke
Reoperation 2 years Reoperation for valve failure
Endocarditis 2 years Prosthetic valve endocarditis