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| Name | Class |
|---|---|
| Department of Cardiovascular Surgery, German Heart Center Munich | UNKNOWN |
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Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St. Jude Trifecta GT) as gold- standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TriRec | Experimental | Trileaflet Reconstruction of the Aortic Valve |
|
| Aortic valve replacement | Experimental | Biological prosthesis, Device: St. Jude Medical Trifecta GT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriRec | Other | Trileaflet Reconstruction of the Aortic Valve |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effective orifice area | Effective orifice area in cm2 (EOA) either after the TriRec- procedure or surgical valve replacement with the St. Jude Medical Trifecta GT Valve, measured by echocardiography | 10th postoperative day +/- 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effective orifice area | Effective orifice area in cm2 (EOA) either after the TriRec- procedure or surgical valve replacement with the St. Jude Medical Trifecta GT Valve, measured by echocardiography | after 6 months, 1 year and thereafter annually until the 10th postoperative year |
| Maximum and mean aortic pressure gradients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markus Krane, MD, PhD | Contact | +4989-1218 | 4111 | krane@dhm.mhn.de |
| Name | Affiliation | Role |
|---|---|---|
| Markus Krane, MD, PhD | Department of Cardiovascular Surgery, German Heart Center Munich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Surgery, German Heart Center Munich | Recruiting | Munich | Bavaria | 80336 | Germany |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Aortic valve replacement |
| Other |
Biological Prosthesis, Device: St. Jude Medical Trifecta GT |
|
| 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. |
| Estimation of aortic regurgitation, if applicable | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year |
| Left ventricular ejection fraction | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year |
| Left ventricular endsystolic and -diastolic diameter | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year |
| Left ventricular endsystolic and -diastolic volume | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year |
| Left atrial diameter | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year |
| Freedom from aortic valve reintervention at discharge | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year |
| Freedom from Mortality | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. |
| Freedom from Stroke | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. |
| Freedom from Myocardial infarction | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. |
| Freedom from conduction disturbances leading to permanent pacemaker implantation | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. |
| Freedom from Endocarditis | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. |
| Freedom from Bleeding requiring re-thoracotomy | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. |
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |