A trial for destination therapy - investigation of non-transplant-eligible patients who are inotrope dependant (INTRePID)

The INTrEPID (Investigation of Non-Transplant-Eligible Patients who are Inotrope Dependant) trial is designed to determine if continuous support with a left ventricular assist system (Novacor LVAS, World Heart Corporation) can reduce mortality and. improve quality of life in end-stage heart failure patients who are dependent on I.V. inotropes and who are ineligible for transplantation. The INTrEPID trial is a FDA approved, prospective, multi-centre, non-randomized controlled trial. The trial consists of two arms, the Device Group (those who receive the Novacor LVAS), and the Control Group (made up of patients meeting all of the entry criteria, but who either, refuse LVAS implantation, do not have access to a device, or have a mechanical aortic valve). The primary endpoint is all cause mortality at 6 months, with secondary endpoints of cardiac mortality at 6 months and health related quality of life assessments. Target enrollment is 110 subjects (55 Device and 55 Control) at 20 Centres. The trial´s feasibility phase (approved for 55 subjects at 10 Centres) is currently underway. To date 42 subjects (14 control group patients and 28 device group patients) have been enrolled. In conclusion, the trial design, target population, inclusion and exclusion criteria, treatment plans and end-points will be discussed.