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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.

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