Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Zimpfer, MD
• Treatments: Anticoagulants; Dabigatran; Phenprocoumon; Warfarin

Criteria

Inclusion Criteria:

• LVAD (HVAD, Heartware Inc., Framingham, MA, USA) implantation more than one month ago

• Stable renal function (clinical judgement)

• Age 18 years or older

• Ability to give informed consent

Exclusion Criteria:

• Severe chronic renal impairment (CL<30)

• History of significant thromboembolic events

• Significant bleeding disorder

• HIV or Hepatitis C infection

• Heparin induced thrombocytopenia

• Known hypersensitivity to Dabigatran or Phenprocoumon