BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 52 / 176

44 Lumax Technical Manual
The study and the control group have similar NYHA classes
and similar rates of improvement in NYHA class from
Baseline to the Six-Month follow-up.
6. The purpose of Secondary Endpoint 6 is to evaluate the rate
of hospitalization, for CHF and for all other causes. The
occurrence rate and reasons for hospitalization of the study
group were compared to the control group. To be consistent
with other large-scale clinical trials, clinical sites were
instructed to report hospitalizations for CHF using the
following definitions: 1) hospitalization for heart failure
management, 2) outpatient visit in which IV inotropes or
vasoactive infusion are administered continuously for at least
4 hours, or 3) emergency room (ER) visit of at least 12 hours
duration in which intravenous heart failure medications
including diuretics are administered.
Table 16 summarizes hospitalization, ER visits and outpatient
visits for enrolled patients.