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28 Stratos LV/LV-T Technical Manual
• The study was designed to enroll 265 patients.
However, the study was terminated early due to slow
patient enrollment. There were no safety issues involved
in the termination decision. Due to the lack of patient
data, the AVAIL CLS/CRT study alone was insufficient to
support CRT pacing effectiveness or an ablate and pace
indication.
• The cumulative enrollment duration was 416.7 months
with a mean duration of 9.7 months for Group 1, 522.4
months with a mean duration of 10.4 months for
Group 2, and 261.1 months with a mean duration of
10.4 months for Group 3. 73 (61.9%) of the study
patients had enrollment durations greater than 6 months.
• There were 158 adverse events (115 observations in
68 patients and 43 complications in 34 patients). There
were no unanticipated adverse device effects reported.
• The overall protocol violation non-compliance rate is
0.4% in Group 1, 0.5% in Group 2, and 0.4% in Group 3.
The overall follow-up compliance rate is 99.8% in all
groups.
• There were 3 patient deaths reported, two in Group 2
and one in Group 3. The clinical investigators and
clinical events committee determined that none of these
deaths were related to the study devices.
• Both the CRT pacing and the RV pacing only groups
showed improvements in the primary composite
endpoint of quality of life and six-minute walk distance
between the baseline evaluation and the six-month
follow-up. In addition, there was a trend towards
improvement between the combined CRT pacing groups
compared to the RV pacing only group at six months.