Any patients ≥18 years old, eligible for transfemoral TAVI with coverage for medical insurance
Conditions
Brief summary
The primary endpoint is defined as the first occurrence, from procedure to hospital discharge, of any event of the composite of all-cause mortality, type 2, 3 or 4 bleeding, major or minor vascular complications, stroke or TIA, myocardial infarction or any red-blood transfusion. The primary endpoint will be blindly determined by a clinical event committee according to the valve Academic Research Consortium-3 (VARC-3 classifications)
Detailed description
Assessment of length of in-hospital stay in days post TAVI procedure, Assessment of the occurrence from procedure to hospital discharge of: Type 2, 3 or 4 bleeding according to the VARC 3 criteria or any red blood cell transfusion of minor or vascular complications. Type 2, 3 or 4 bleedings or red blood cell transfusion. Any red blood cell transfusion Type 2, 3 or 4 bleedings, Assessment of an interaction in the impact of systematic antagonization according to the use or not of an echo-guided femoral puncture and/or arterial radial access. These subgroups are defined at the time of randomization by stratification., Assessment of the occurrence from procedure to hospital discharge of: Death or type 2, 3 or 4 bleedings Any kidney injury, stage 2 to 4 according to the KDIGO definition Death, type 2, 3 or 4 bleedings or stroke De a th, VARC 3 type 2-3-4 bleeding or Any red blood cell transfusion, MI or stroke Or TIA Any myocardial infarction, stroke or TIA Type 3 or 4 bleeding Type 2 bleeding Minor vascular complications Access site and access related vascular injury according to VARC-3 criteria
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as the first occurrence, from procedure to hospital discharge, of any event of the composite of all-cause mortality, type 2, 3 or 4 bleeding, major or minor vascular complications, stroke or TIA, myocardial infarction or any red-blood transfusion. The primary endpoint will be blindly determined by a clinical event committee according to the valve Academic Research Consortium-3 (VARC-3 classifications) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of length of in-hospital stay in days post TAVI procedure, Assessment of the occurrence from procedure to hospital discharge of: Type 2, 3 or 4 bleeding according to the VARC 3 criteria or any red blood cell transfusion of minor or vascular complications. Type 2, 3 or 4 bleedings or red blood cell transfusion. Any red blood cell transfusion Type 2, 3 or 4 bleedings, Assessment of an interaction in the impact of systematic antagonization according to the use or not of an echo-guided femoral puncture and/or arterial radial access. These subgroups are defined at the time of randomization by stratification., Assessment of the occurrence from procedure to hospital discharge of: Death or type 2, 3 or 4 bleedings Any kidney injury, stage 2 to 4 according to the KDIGO definition Death, type 2, 3 or 4 bleedings or stroke De a th, VARC 3 type 2-3-4 bleeding or Any red blood cell transfusion, MI or stroke Or TIA Any myocardial infarction, stroke or TIA Type 3 or 4 bleeding | — |
Countries
France