Status: Active, not recruiting
Keywords: Heart Failure , LVAD , Left Ventricular Assist Device , Heart Recovery
IRB Number: 00063817
Specialty: Cardiology, Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiothoracic Surgery, Cardiology
Sub Specialties: Heart Failure, Cardiac Mechanical Support, Heart Failure, Echocardiography
The primary objective of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function (remission from HF) after undergoing a standardized LVAD plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months.
The secondary objectives of this study are to determine the durability of sustained remission from HF following LVAD explantation at 12 months and up to 3 years as well as determine the predictors of recovery.
This is a non-randomized, prospective, multi-center study. Forty subjects satisfying the inclusion and exclusion criteria will be recruited at participating centers. Subjects will be recruited to the trial in a preliminary manner prior to LVAD implantation or within 4 weeks of LVAD implantation.
Subjects will be followed for up to 3 years after explantation of the device, or until heart transplantation. All participating centers will maintain a screening log of patients with cardiomyopathy undergoing LVAD implantation.