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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
| Software for Trials Europe GmbH | UNKNOWN |
| Institut für Pharmakologie und Präventive Medizin | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVR + CABG | Patient receiving AVR combined with CABG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVR and CABG | Procedure | Combined AVR with CABG |
|
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | death from any reason | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an indication for AVR combined with CABG who will receive an Edwards Intuity Elite rapid deployment aortic valve prosthesis.
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| Name | Affiliation | Role |
|---|---|---|
| Anno Diegeler, Prof. | Campus Bad Neustadt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Bad Neustadt | Bad Neustadt an der Saale | Bavaria | 97616 | Germany |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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