First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF.

Background: The Food and Drug Administration (FDA) initiated the Expedited Access Pathway (EAP) to accelerate approval of novel therapies targeting unmet needs for life-threatening conditions. EAP allows for the possibility of initial FDA approval using intermediate end points with postapproval demonstration of improved outcomes.

Objective: Describe the EAP process using the BeAT-HF trial as a case study.

Influence of diabetes on cardiac resynchronization therapy with or without defibrillator in patients with advanced heart failure.

Objectives: We performed a post hoc analysis to determine the influence of cardiac resynchronization therapy with a defibrillator (CRT-D) or without a defibrillator (CRT-P) on outcomes among diabetic patients with advanced heart failure (HF).

Background: In patients with systolic HF, diabetes is an independent predictor of morbidity and mortality. No data are available on its impact on CRT-D or CRT-P in advanced HF.