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Approval was based on a study of 691 patients with first-, second-, or third-degree AV block, New York Heart Association (NYHA) class I-III heart failure, and left ventricular ejection fraction (LVEF) less than 50%, in which biventricular pacing over three years reduced all-cause mortality by 26%, reduced heart failure-related urgent care, and increased LV end-systolic volume index by more than 15%.

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AHA heart failure guidelines recommend consideration of cardiac resynchronization therapy (CRT) for patients with heart failure who have indications for permanent pacing (eg, first implant, upgrading of a conventional pacemaker) and NYHA class III-IV symptoms or those who have an LVEF less than 35% despite being on optimal heart failure therapy and who may have a dependence on RV pacing.

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