Stopped: safety reasons
Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct thrombin inhibitor dabigatran may represent an alternative to Coumarin for long-term anticoagulation. In this pilot single-center study, thirty LVAD patients with stable renal function were scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after implantation of a HeartWare HVAD system following an open-label balanced parallel group design.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications
Timeframe: through study completion, an average of 1 year
Number of major and minor bleeding events (INTERMACS definition)
Timeframe: through study completion, an average of 1 year
Number of patients with necessary treatment changes
Timeframe: through study completion, an average of 1 year
Patient contentment (regular assessment with questionnaire)
Timeframe: Change of Baseline Patient Contentment at 12 months