Severe Symptomatic Aortic Stenosis
Conditions
Brief summary
All-cause mortality at 12 months after TAVI, Transient ischemic attack (TIA) or stroke at 12 months after TAVI, Myocardial infarction at 12 months after TAVI, Bleeding at 12 months after TAVI according BARC, Net Adverse Clinical Event(s)
Detailed description
All major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC, Incidence of subclinical valve thrombosis (SVT) detected by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) at 3 and 12 months after TAVI assessed by 4-dimensional computed tomography (4DCT) imaging (performed only in pre-specified centers), Gender, Age, Valve type, Comorbilities, All-caused mortality at 12 months after TAVI, Stroke/TIA at 12 months after TAVI, Myocardial infarction at 12 months after TAVI, Progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography at 12 months after TAVI, Thrombotic and bleeding risk score
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 12 months after TAVI, Transient ischemic attack (TIA) or stroke at 12 months after TAVI, Myocardial infarction at 12 months after TAVI, Bleeding at 12 months after TAVI according BARC, Net Adverse Clinical Event(s) | — |
Secondary
| Measure | Time frame |
|---|---|
| All major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC, Incidence of subclinical valve thrombosis (SVT) detected by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) at 3 and 12 months after TAVI assessed by 4-dimensional computed tomography (4DCT) imaging (performed only in pre-specified centers), Gender, Age, Valve type, Comorbilities, All-caused mortality at 12 months after TAVI, Stroke/TIA at 12 months after TAVI, Myocardial infarction at 12 months after TAVI, Progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography at 12 months after TAVI, Thrombotic and bleeding risk score | — |
Countries
Italy, Portugal, Spain