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Stratos LV/LV-T Technical Manual 21
Clinical Endpoints
Primary Endpoint: Complication-free Rate (Safety)
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 right ventricular, the left
ventricular lead, lead ventricular lead adapters (if used) and the
implant procedure. The target complication-free rate at six
months is 85%.
Primary Endpoint: Six Minute Walk Test & QOL (Effectiveness)
The purpose of Primary Endpoint 1 was to evaluate the
effectiveness of the CRT (Groups 1 and 2) compared to RV only
(Group 3) pacing as measured by the average composite rate of
improvement in six minute walk test and QOL.
Accountability of PMA Cohorts
After randomization and enrollment, 23 patients (8 in Group 1, 8
in Group 2 and 7 in Group 3) did not receive an implant. The
reasons for patients not receiving an implant are outlined in
Figure 1
. Two additional patients in Group 1 had an
unsuccessful first implant attempt (unable to implant the LV
lead), but follow up data was not received.