Effect of BivaliRudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 526

Inclusion Criteria

All patients =18 years of age who are deemed appropriate candidates at high surgical risk(Euroscore =18,or considered inoperable)undergoing TAVR via transfemoral arterial access, that have provided written informed consent before initiation of any study related procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 186
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 434

Exclusion Criteria

1. Contraindication to bivalirudin 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 Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The hypothesis is that bivalirudin will reduce bleeding rates compared to UFH, and will improve the overall clinical outcomes of TAVR patients.;Secondary Objective: None;Primary end point(s): Major bleeding(Bleeding Academic Research Consortium[BARC]type = 3) at 48 hours or hospital discharge, whichever occurs first, and Net Adverse Clinical Events [NACE(including major bleeding, death, myocardial infarction [MI],and stroke) at 30 days.;Timepoint(s) of evaluation of this end point: 48 hours or prior to hospital discharge (whichever occurs first). co-primary end-point: 30 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (1) Major bleeding according to additional scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS); (2)minor bleeding (BARC type 1 and 2 and TIMI minor); (3) major adverse cardiac events (MACE) including death, non-fatal MI, and stroke; (4) the rates of the individual components of MACE; (5) transient ischemic attack; (6) acute kidney injury; (7) VARC major vascular complications; (8) acquired thrombocytopenia; (9) rate of new post-procedural atrial fibrillation/flutter; (10) economic analysis of using bivalirudin in TAVR.;Timepoint(s) of evaluation of this end point: 48 hours or prior to hospital discharge (whichever occurs first) and at 30 days