At a glance
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The Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity, a RAndomized Controlled Trial (VAFRACT)
In Brief
A clinical study evaluating echo-optimization for Heart Failure. Completed, enrolled 27 participants across 1 site.
Detailed Summary
After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile and could provide an improvement on functional capacity (FC). VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by cardiopulmonary exercise test (CPET), in LVAD optimization free population.
Study Details
Timeline
Interventions
LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.