User Manual

Lumax Technical Manual 49
1.6.3.2 Methods
The study primarily evaluates and compares the functional
benefits of the Lumax HF-T with OPT versus the Lumax HF-T
with SIM using an endpoint that includes both a 6-minute walk
(6MW) test and quality of life (QOL) measurement assessed
using the Minnesota Living with Heart Failure questionnaire
(MLWHFQ). As such, relevant measurements are completed 3
times for each patient: once at the baseline evaluation (up to 14
days after enrollment), once at the 1-month follow-up (30 days
after baseline) and once at the 2-month follow-up (30 days after
the 1-month follow-up). Baseline data is collected with the
Lumax HF-T programmed to SIM.
6MW testing was chosen as a meaningful measure of CRT
therapy effect on HF status because 6MW has been shown to
improve during chronic CRT therapy (Olsson LG, Swedberg K,
Clark AL et al. Six minute corridor walk test as an outcome
measure for the assessment of treatment in randomized, blinded
intervention trials of chronic heart failure: a systematic review. Eur
Heart J 2005; 26:778–793.) Example improvements of 6MW
include increase in the range of 20 meters.
In this trial, the intent was to detect any loss of CRT benefit by
assessing the incidence of HF “worsening”, defined as reduction
of 35 meters distance on 6MW during CRT with V-V
programmability and optimization compared to during CRT
without V-V programmability and optimization.
QOL testing was chosen as a meaningful measure of CRT
therapy effect on HF status because QOL has been shown to
improve during chronic CRT therapy (Albouaini K, Egred M, Rao
A, et al. Cardiac resynchronisation therapy: evidence based
benefits and patient selection. Eur J Intern Med. 2008
May;19(3):165-72) Example magnitude improvements of QOL
include change in the range of 10 points.
In this trial, the intent was to detect any loss of CRT benefit by
assessing the incidence of HF “worsening”, defined as increase
of 10 points in QOL score by MLWHFQ during CRT with V-V
programmability and optimization compared to during CRT
without V-V programmability and optimization.
Worsening in the trial was defined as either a worsening (as
defined) in 6MW or in QOL score during CRT with V-V
programmability and optimization.