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44 Stratos LV/LV-T Technical Manual
The freedom from Stratos LV system-related and procedure-
related complications was 88.76% with a one sided lower 95%
confidence bound of 81.69%. Therefore, the null hypothesis was
rejected, and it was concluded that the complication-free rate at
6 months is equivalent to 85% within 10% (p = 0.0014).
Observed Adverse Events
Adverse events are classified as either observations or
complications. Observations are defined as clinical events that
do not require additional invasive intervention to resolve.
Complications are defined as clinical events that require
additional invasive intervention to resolve.
Of the 29 adverse events reported, there were 18 observations
and 11 complications in a total of 89 patients. Table 10
and
Table 11
provide a summary by category of each type of
adverse event (complications and observations).
Table 10: Summary of Complications at 6 months
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Corox OTW/Steroid Lead-Related
Loss of
capture
2 2.2% 2 0.03
Phrenic nerve
stimulation
1 1.1% 1 0.02
Total
3 3.3% 3 0.05
Atrial Lead Related
Loss of
capture
1 1.1% 1 0.02
Total
1 1.1% 1 0.02
RV Lead Related
Loss of
capture
3 3.3% 3 0.05
Elevated
Pacing
thresholds
2 2.2% 2 0.03
Total
5 5.6% 5 0.08