Heart Failure Clinical Trial
Official title:
Hemodynamic and Clinical Effects of Continuous Right Ventricular Pacing in the Early Post-operative Period After Left Ventricular Assist Device Implantation
Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left
ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart
failure. However, little is known about RV pacing in patients with advanced heart failure
treated with an implantable left ventricular assist device (LVAD). The univentricular
support provided by contemporary continuous flow LVAD's has improved outcomes for many
advanced heart failure patients, yet the incidence of RV failure in the early post-operative
period following implantation is associated with significantly reduced survival and
increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on
RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony,
RV overdrive pacing may counteract these adverse mechanical alterations, improving RV
systolic function and ultimately LVAD function.
The investigators will recruit all patients referred for an implantable, continuous flow
LVAD at Duke University Medical Center who have an existing implantable dual-chamber
cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to
compare continuous right ventricular pacing vs. native ventricular conduction at equivalent
heart rates. Multiple clinical outcomes will be examined over a two week period
post-operatively including invasive hemodynamics, vasoactive medication use, end-organ
function, RV function by Echocardiography as well as patient symptoms and functional status.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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