Ventricular Dysfunction Clinical Trial
Official title:
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).
Prolonged pacing from the right ventricular (RV) Apex has been shown to be associated with
progressive left ventricular (LV) dysfunction. This has led to an interest in alternative
right ventricular pacing sites. Only very few studies investigated the effect of alternative
right ventricular pacing sites using three dimensional imaging. Using cardiac MRI volumetric
left- and right ventricular analysis and three-dimensional reconstruction is more accurate
compared to trans-thoracic echocardiogram. St. Jude Medical has developed a MRI conditional
pacemaker system enabling for the first time to investigate alternative pacing sites using
cardiac MRI.
Patients already implanted with an MRI conditional pacemaker system from St. Jude Medical
will be enrolled in that study and subdivided into 4 groups (right ventricular pacing lead
positioned apically or septally subdivided in patients paced for <50% of time or 50% or
more). All patients will undergo cardiac MRI at enrollment and again 12 months later.
Patients paced <50% of the time will undergo cardiac MRI with and without pacemaker
stimulation at both visits.
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