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| Name | Class |
|---|---|
| University College, London | OTHER |
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.
Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Sutureless" valve | Other | Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted. |
|
| "Sewed-in" valve | Other | Patients who underwent aortic valve replacement with a "sewed-in" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac CT-scan | Radiation | ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs). In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of maximum and minimum velocity under patient specific conditions | between 6 months and 4 years after aortic valve replacement | |
| Comparison of the effective orifice area under patient specific conditions | between 6 months and 4 years after aortic valve replacement | |
| Comparison of the percentage of turbulent flow under patient specific conditions | between 6 months and 4 years after aortic valve replacement | |
| Comparison of the pressure drop under patient specific conditions | between 6 months and 4 years after aortic valve replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients. | The first secondary outcome measure is the comparison of -pressure gradients as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified. If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claus Rath, MD | Contact | 0043-1-40400-69660 | claus.rath@meduniwien.ac.at | |
| Martin Andreas, MD | Contact | 0043-1-40400-69660 | martin.andreas@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Alfred Kocher, MD | Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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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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|
| between 6 months and 4 years after aortic valve replacement |
| Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity. | The second secondary outcome measure is the comparison of -peak velocity as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified. If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics." | between 6 months and 4 years after aortic valve replacement |
| D014694 |
| Ventricular Outflow Obstruction |