Table 1.

Inclusion and exclusion criteria for BIOCRT study.

Inclusion Criteria Study participant with an approved indication for a CRT or CRT-D system NYHA Class II-IV heart failure unresponsive to drug therapy EF<35% QRS>120 ms Patient receiving optimal medical therapy including ACE inhibitor or ARB, Beta-blocker, and diuretic Patient with history of significant congestive decompensation events within the last 12 months

Exclusion Criteria NYHA Class I heart failure Co-morbidities which may limit lifespan to <6 months Severe aortic stenosis (valve area<1.0 cm2) History of cardiac surgery or intervention within the preceding 90 days History of moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for COPD flare-up Pregnancy History of primary pulmonary hypertension Patient on continuous or intermittent infusion therapy for heart failure

CRT denotes cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy-defibrillator; NYHA, New York Heart Association; EF, ejection fraction; ACE, angiotensin converting enzyme; ARB, angiotensin receptor blocker.