Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer "Rapid Deployment" Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Campus Bad Neustadt
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- all-cause mortality
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a prospctive, unrandomized multicentric registry which will enrol patients with an indication for aortc valve replacement combined with myocardial reperfusion (CABG). The registry will collect patient specific baseline data and established risk scores (Logistic Euroscore I & II, STS-Score, KBA Score) to enable us to make an estimate about the perioperative risks.
Detailed Description
Aortic replacement combined with coronary bypass surgery has an impact on the risk profile for the direct postoperative course and also on the long-time survival perspective. The advantage of rapid deployment aortic valve prostheses, like the Edward Intuity Elite Valve that is used in this registry, is the greater ease of implantation, because only a few sutures are necessary to secure the device compared to a conventional prosthesis, where more then ten sutures are needed. In procedures where the aortic valve replacement (AVR) is combined with a coronary artery bypass graft (CABG), the use of a rapid deployment valve can shorten the duration of cardiac ischemia and the overall intervention duration, which possibly has an influence on clinical results.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •patients with aortic valve stenosis and coronary heart disease with indication for AVR and CABG
- •patients in who the Edwards Intuity Elite valve is to be implanted
- •patients who are planned to receive at least one coronary bypass
- •patients who have signed an informed consent form
Exclusion Criteria
- •Exclusion Criteria:
- •emergency surgery
- •re-operation (i.e. any previous opening of pericardium)
- •additional heart diseases requiring heart surgery (e. g. subvalvular myectomy and ablation, but not atrial auricle closure or resection)
- •legal incapacity or other circumstances that impair the patient's ability to understand the nature, meaning or extent of the trial
- •patients wanting a mechanical prosthesis
- •patients with contraindications for the Edwards Intuity Elite Valve
- •acute endocarditis or other systemic infections
Outcomes
Primary Outcomes
all-cause mortality
Time Frame: 30 Days
death from any reason