User Manual

Lumax Technical Manual 31
1.6.2.2 Methods
Primarily, the study evaluates and compares the functional
benefits of CRT between the two randomized groups using a
composite endpoint consisting of a six-minute walk test (meters
walked) and quality of life measurement (assessed using the
Minnesota Living with Heart Failure Questionnaire). Relevant
measurements were completed twice for each patient: once at
the Baseline evaluation (two-week post implant follow-up) and
again at a six-month follow-up evaluation. The data collected
during this clinical study was used to demonstrate equivalent
treatment of CHF in both the study and control groups. This study
also evaluated other outcomes including: the effectiveness of
atrial therapy to automatically convert atrial tachyarrhythmias, the
percentage of time CRT is delivered, and other measures of CHF
status including NYHA classification, peak oxygen consumption
during metabolic exercise testing, and the rate of hospitalization
for CHF.
Inclusion Criteria
To support the objectives of this investigation, patients were
required to meet the following inclusion criteria prior to
enrollment:
 Stable, symptomatic CHF status
 NYHA Class III or IV congestive heart failure
 Left ventricular ejection fraction  35% (measured within
Six-Months prior to enrollment)
 Intraventricular conduction delay (QRS duration greater
than or equal to 130 ms)
 For patients with an existing ICD/CRT-D, optimal and
stable CHF drug regimen including ACE-inhibitors and
beta-blockers unless contraindicated (stable is defined as
changes in dosages less than 50% during the last 30
days)
 Indicated for ICD therapy
 History or significant risk of atrial tachyarrhythmias
 Willing to receive possibly uncomfortable atrial shock
therapy for the treatment of atrial tachyarrhythmias
 Able to understand the nature of the study and give
informed consent
 Ability to tolerate the surgical procedure required for
implantation