Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 870

Inclusion Criteria

Patients may be included in the study if they meet all of the following criteria:
1. = 18 years of age
2. High risk (Euroscore =18, or considered inoperable) for surgical aortic valve replacement
3. Undergoing TAVR via transfemoral arterial access
4. Provide written informed consent before initiation of any study related procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 261
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 609

Exclusion Criteria

Patients will be excluded from the study if any of the following exclusion criteria apply prior to enrollment:
1. Any known contraindication to the use of bivalirudin (except presence of severe renal impairment [GFR<30 ml/min] since these patients will be included in the trial - please see protocol section 8.1.1) or UFH
2. Refusal to receive blood transfusion
3. Mechanical valve (any location) or mitral bioprosthetic valve
4. Extensive calcification of the common femoral artery, or minimal luminal diameter < 6.5 mm
5. Use of elective surgical cut-down for transfemoral access
6. Concurrent performance of percutaneous coronary intervention with TAVR
7. International normalized ratio (INR) = 2 on the day of TAVR procedure, or known history of bleeding diathesis
8. History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation
9. Severe left ventricular dysfunction (left ventricular ejection fraction<15%)
10. Severe aortic regurgitation or mitral regurgitation (4+)
11. Hemodynamic instability (e.g. requiring inotropic or IABP support) within 2 hours of the procedure
12. Dialysis dependent
13. Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure
14. Acute myocardial infarction, major surgery or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within
30 days
15. Percutaneous coronary intervention within 30 days
16. Upper gastrointestinal or genitourinary bleed within 30 days
17. Stroke or transient ischemic attack within 30 days
18. Any surgery or biopsy within 2 weeks
19. Administration of: a. UFH within 30 minutes of the procedure, b. Enoxaparin within 8 hours of the procedure c. Fondaparinux or other LMWHs within 24 hours of the procedure d. Dabigatran, rivaroxaban or other oral anti-Xa or antithrombin agent within 48 hours of the procedure e. Thrombolytics, GPI, or warfarin within 72 hours of the procedure
20. Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast
21. Contraindications or allergy to aspirin or clopidogrel
22. Known or suspected pregnant women, or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy.
23. Previous enrolment in this study
24. Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached