Exclusion criteria# 4 “New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks” may be problematic for enrollment. The way that interprets is that anyone hospitalized with HF couldn’t be enrolled regardless of class.

Consistent with the current FDA label for dronedarone, patients who have been hospitalized in the last 4 weeks with acute heart failure are not eligible for treatment with dronedarone. If a patient has no recent HF hospitalization but has advanced HF (class III or IV) they are also ineligible. Thus, persons with NYHA 1-2 heart failure and no hospitalization for HF in the last 4 weeks are eligible for CHANGE AFIB.