Aortic Valve Insufficiency Clinical Trial
Official title:
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)
This is an international, multicenter, open-label, randomized controlled trial. All patients undergoing transfemoral TAVR at the participating centers will be eligible. All sites will initiate enrolment with 2 feasibility roll-in bivalirudin treated patients and thereafter patients will be randomly assigned to either standard dosing of bivalirudin or UFH as control. The 2 roll-in cases per site will constitute the feasibility cohort that will be followed and analyzed separately. Patients will undergo TAVR according to current standard of care practices at the treating centers. Use of antiplatelet agents pre, during, and post procedure, and possibly oral anticoagulants post procedure, will be according to the sites' standard practice. ALL available data will be collected in the eCRF prospectively
This study will be an international, multi-center, open-label, randomized controlled trial in patients undergoing TAVR. Following the conclusion of the roll-in phase of 2 patients per site, who will comprise the feasibility cohort of approximately 70 patients, 550 patients will be randomized to bivalirudin or UFH at approximately 35 centers. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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