Registry to Gather Long-time Results After Surgical Aortic Valve Replacement With a Rapid Deployment Aortic Valve Prothesis (Edwards Intuity) Combined With Bypss Surgery (CABG)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Register Zur Erhebung Von Langzeitergebnissen Nach Chirurgischem Aortenklappen Ersatz Mit Einer Rapid Deployment Aortenklappenprothese (Edwards Intuity) in Kombination Mit Einer Bypassoperation (CABG)

Conditions
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Aortic Valve Stenosis, Coronary Artery Disease

Intervention / Treatment
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* Procedure: AVR and CABG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AVR + CABG<br>Patient receiving AVR combined with CABG | Procedure: AVR and CABG<br>* Combined AVR with CABG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | death from any reason | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Stenosis, Rapid deployment Valve, CABG, Edwards Intuity Elite