Use Instructions

32
BAT
(N=125)
Control
(N=134)
Serious Adverse
Event
Number
of Events
(#
subjects)
Event Rate
per patient
year of
follow-up
Number
of Events
(#
subjects)
Event Rate
per
patient
year of
follow-up
Relative
Reduction in
Event Rate
(95% CI)
p-value
Cardiac
Arrhythmias/Cardiac
Arrest
8 (6)
0.054
18 (12)
0.109
0.50 (-0.14, 0.78)
0.100
Hypotension/Syncope
2 (2)
0.014
6 (4)
0.036
0.63 (-0.85, 0.92)
0.226
MI/Angina
5 (4)
0.034
10 (10)
0.060
0.44 (-0.63, 0.81)
0.288
Total
15 (11)
0.101
34 (22)
0.206
0.51 (0.10,
0.73)
0.023
There were no unanticipated adverse events reported in the study.
Effectiveness Results
Six-minute hall walk (6MHW) performed according to a standard protocol, Minnesota Living
With Heart Failure Quality of Life (MLWHF QOL) Questionnaire data, and a blinded core lab
evaluated NT-proBNP were collected at the baseline visit and during follow-up at 6-
months. The 6 month results are reported below in the Expedited Phase Efficacy Analysis
for the Intended Use Population subjects.
Within the population supporting the Expedited Phase, there are two cohorts of data.
Data that was previously analyzed in the original PMA Clinical Report, dated December 14,
2018, called the initial data, and data that has not been previously unblinded and
analyzed and is included here, called the second data, that was collected through April
22, 2019. Unless otherwise specified, the data presented is the Initial Cohort and Second
Cohort.
Table 8 below shows the six-minute walk differences between the arms in the Second and
Initial Cohorts for the Intended Use Population. The results showed a consistent and
clinically meaningful and statistically significant improvement between the arms for the
Initial, the Second and Combined Cohorts.
Table 9: Change in Six Minute Walk Distance at 6 Months – Intended Use
Second, Initial and Combined Cohorts
BAT + Medical
Management
Medical
Management
Difference*
Cohort
N
Mean±SD
(95% CI)
N
Mean±SD
(95% CI)
Δ Means
(95% CI)
p-
value
Initial
69
49.0 ± 71.6
(31.8, 66.2)
80
-11.9 ± 92.8
(-32.5, 8.8)
65.4
(38.5, 92.3)
<0.001