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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifecta aortic xenograft | Active Comparator | The Trifecta aortic xenograft is implanted in these patients. |
|
| Magna Ease aortic xenograft | Active Comparator | The Magna Ease aortic xenograft is implanted in these patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic xenograft | Device | After randomization, the aortic xenograft is implanted in the standard fashion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transprosthetic pressure gradient at stress exercise echocardiography | Echo at follow up stress echo (at 10 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Transprosthetic pressure gradient at discharge echo | Echo at discharge (usually postoperative day 5 to 7) | |
| Left ventricular mass regression calculated by echocardiography (gram) | Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months) |
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Inclusion Criteria:
Patients between 18 and 75 years
Elective aortic valve replacement in patients with predominant aortic stenosis
Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
Native German speakers (quality of life questionnaire in German language)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerckhoff Klinik | Bad Nauheim | 61231 | Germany |
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| Quality of life using the EQ-5D-3L questionnaire | 1 to 5 days before surgery and at follow up (10 months) |
| BNP plasma level | 1 to 5 days before surgery and at follow up (10 months) |