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Dabigatran in Patients With Atrial Fibrillation and Mitral Biological Prostheses

Atrial Fibrillation Clinical Trial

Official title:
The Use of Dabigatran Etexilate in Patients With Atrial Fibrillation After Mitral Valve Prosthetic Replacement

Clinical Trial Summary

The efficacy and safety of anticoagulation therapy using dabigatran in comparison with warfarin will be evaluated in patients with atrial fibrillation after mitral valve prosthetic replacement concomitant with Cox-Maze procedure.

Clinical Trial Description

Patients with prosthetic mitral valves need a long-term anticoagulation therapy. After mitral valve replacement using mechanical prostheses warfarin is administrated during the whole life. Biological prostheses allows do discontinue anticoagulation 3 months after surgery in the absence of other risk factors of thrombosis especially atrial fibrillation. The common approach to patients with mitral valve disease and atrial fibrillation is mitral valve prosthetic replacement concomitant to Cox-Maze procedure. This allows to maintain sinus rhythm in 65-80% of patients. In the study the safety and efficacy of dabigatran in comparison with warfarin will be evaluated after the mitral valve surgery and Cox-Maze procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03183843
Study type Interventional
Source Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Contact
Status Enrolling by invitation
Phase Phase 4
Start date June 29, 2016
Completion date December 1, 2018
View Details
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