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| Name | Class |
|---|---|
| FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI).
- The main objective is to determine whether the high residual platelet reactivity rates in patients undergoing TAVI is associated with the occurrence of clinical and / or subclinical prosthetic valve thrombosis measured by echocardiography and multi-slice computerized tomography
For the purpose of the study, platelet reactivity will be measured with the commercial kit PLT VASP/P2Y12 at baseline, 1day and 3 months postprocedure.
Secondary objectives include: -Determine the variability of platelet aggregation measured at baseline before the procedure, 1-day post-procedure and at 3-6 and 1 year follow-up.
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| Measure | Description | Time Frame |
|---|---|---|
| The association between high residual platelet reactivity rates in patients undergoing TAVI with the occurrence of clinical and / or subclinical prosthetic valve thrombosis | platelet reactivity will be measured with the commercial kit platelet Vasodilator Stimulated Phosphoprotein (VASP)/P2Y12 and subclinical valve thrombosis by transthoracic echocardiography and multi-slice computerized tomography | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the variability of platelet aggregation | platelet aggregation | at baseline, 1 day post-procedure and at 3-6 months and 1 year follow-up. |
| To quantify the pro-thrombotic inflammatory response |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe symptomatic aortic stenosis treated with TAVI
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Not yet recruiting | Barcelona | Spain |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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measured by serum levels of (cluster of differentiation 14) CD14 + and (cluster of differentiation 16) CD16 +
| at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up. |
| To correlate of Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis | Serum Von Willebrand factor levels and distribution of Von Willebrand factor multimers with the appearance of prosthetic thrombosis assessed by transthoracic echocardiography or multi-slice computerized tomography | at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up. |
| To correlate residual platelet reactivity with clinical events | platelet aggregation | at baseline, 1 day post-procedure and at 3, 6 months and 1 year follow-up. |
| To evaluate clinical factors associated with the appearance of early prosthetic thrombosis. | to perform Multislice computerized tomography and clinical follow-up | multi slice computerized tomography at 3 month and clinical up to 1 year. |
| Hospital Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
|
| D014694 |
| Ventricular Outflow Obstruction |