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Stratos LV/LV-T Technical Manual 31
Table 4: AVAIL CLS/CRT Complication-Free Rate at
6 months – Stratos LV
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Other Medical
Worsening
CHF
2 2.7% 2 0.03
Repeat
Ablation
3 4.0% 3 0.05
Non-CHF
cardiac
symptoms
3 4.0% 3 0.05
Other Medical
3 4.0% 3 0.05
Total 10 13.3% 11 0.17
Total—All
Patients and
Categories
19 25.3% 24 0.37
Number of Patients = 75 Number of Patient-Years = 64.4
The freedom from Stratos LV system-related and procedure-
related complications was 85.33%, with a one sided lower 95%
confidence bound of 76.89%. Therefore, the procedure, lead and
device related complication-free rate at 6 months met the pre-
specified acceptance criterion of equivalence (non-inferiority)
within 10% of 85% (p = 0.0196).
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 104 adverse events reported in the Stratos LV study
groups, there have been 76 observations in 45 patients and 28
complications in 20 patients with a cumulative enrollment
duration of 64.4 patient-years. 26.7% of the enrolled Stratos LV
patients have experienced a complication. The rate of
complications per patient-year is 0.43. 60.0% of the enrolled
study patients have a reported observation. The rate of
observations per patient-year is 1.18.