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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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The primary purpose of this study is electronic data collection of arterial pressure waveform signals in patients with Aortic Stenosis. The collected digital pressure waveform data will be used to assess the feasibility of using the arterial pressure signal as a decision support tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic parameters before and after valve repair and its correlation with outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients for TAVR | Patients for TAVR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexfin measuremtents | Device | There will be only observational recordings, no interevntion |
|
| Measure | Description | Time Frame |
|---|---|---|
| the distinctive morphological characteristics of the aortic pressure waveform | the distinctive morphological characteristics of the aortic pressure waveform | During procedure and 4 hours after |
| Measure | Description | Time Frame |
|---|---|---|
| changes in hemodynamic variables after TAVR and its influence on cardiac recovery. | during procedure and up to 6 weeks after intervention |
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Inclusion Criteria:
o Patients with severe senile degenerative aortic valve stenosis
Exclusion Criteria:
o Patients with contraindications for placement of aortic catheter
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patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) procedures
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veelo | Recruiting | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38509415 | Derived | Kho E, Schenk J, Vlaar APJ, Vis MM, Wijnberge M, Stam LB, van Mourik M, Jorstad HT, Hermanns H, Westerhof BE, Veelo DP, van der Ster BJP. Detecting aortic valve stenosis based on the non-invasive blood pressure waveform-a proof of concept study. Geroscience. 2024 Dec;46(6):5955-5965. doi: 10.1007/s11357-024-01136-w. Epub 2024 Mar 20. | |
| 36187009 |
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| Schenk J, Kho E, Rellum S, Kromhout J, Vlaar APJ, Baan J, van Mourik MS, Jorstad HT, van der Ster BJP, Westerhof BE, Bruns S, Immink RV, Vis MM, Veelo DP. Immediate reduction in left ventricular ejection time following TAVI is associated with improved quality of life. Front Cardiovasc Med. 2022 Sep 16;9:988840. doi: 10.3389/fcvm.2022.988840. eCollection 2022. |
| ID | Term |
|---|---|
| C562942 | Aortic Valve, Calcification of |
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