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Stratos LV/LV-T Technical Manual 47
1.7.3 AVAIL and OVID Combined Primary
Endpoint-Complication-free Rate (Safety)
The results from for the AVAIL CLS/CRT and OVID studies were
pooled to evaluate the safety of the Stratos LV device. The
safety of the Stratos LV was evaluated based on complications
(adverse events that require additional invasive intervention to
resolve) related to the implanted CRT system which includes the
Stratos LV, the atrial lead, the right ventricular lead, the left
ventricular lead and the implant procedure. The target
complication-free rate at six months was 85%.
Twenty-three (23) complications in these categories were seen
in 21 patients with cumulative implant duration of 127.7 years.
12.8% of the patients had a reported complication in these
categories. The rate of complications per patient-year was 0.18.
Details of the Stratos LV complications in the AVAIL CLS/CRT
and OVID studies are listed in Table 12
.
Table 12: OVID and AVAIL Complication-Free
Rate - Stratos LV
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
LV Lead-Related
High
Threshold / No
Capture
3
1.8%
3 0.02
Diaphragmatic
Stimulation
2
1.2%
2 0.02
Dislodgement 1
1.2%
2 0.01
Total 7 4.3% 7 0.06
RV Lead Related
High
Threshold / No
Capture
9 5.5% 9 0.07
Total 9 5.5% 9 0.07
Atrial Lead Related
No Capture
1 0.6% 1 0.01
Total 1 0.6% 1 0.01