BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 38 / 176

30 Lumax Technical Manual
1.6.2.1 Study Overview
The purpose of the prospective, randomized, multi-center
OPTION CRT/ATx study was to demonstrate the safety and
effectiveness of the investigational Tupos
LV/ATx Cardiac
Resynchronization Therapy Defibrillator (CRT-D) in patients with
congestive heart failure (CHF) and atrial tachyarrhythmias.
Patients in the study group were implanted with a BIOTRONIK
Tupos LV/ATx. Patients in the control group were implanted with
any legally marketed CRT-D. Patients in both the study and
control groups were implanted with a legally marketed left
ventricular lead.
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)